MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48003015X

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Event Description

As reported, the balloon of a saber 3mm 15cm 150 ruptured below rbp during the operation.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop or while removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks, or any other damages noted to the device prior to inserting into the patient.The device was prepped per the ifu.The intended procedure was to dilate the lesion which had a stenosis.There was no resistance/friction experienced while inserting the balloon catheter through the rotating hemostatic valve or through the guide catheter.The catheter advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend or was never kinked while being used.The inflation device used was used successfully with out devices.The product was removed from the patient intact (in one piece).It was noted that balloon was not in a stent when it ruptured.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82233451 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a saber 3mm 15cm 150 ruptured below rbp during the operation.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop or while removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks, or any other damages noted to the device prior to inserting into the patient.The device was prepped per the ifu.The intended procedure was to dilate the lesion which had a stenosis.There was no resistance/friction experienced while inserting the balloon catheter through the rotating hemostatic valve or through the guide catheter.The catheter advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend or was never kinked while being used.The inflation device used was used successfully with other devices.The product was removed from the patient intact (in one piece).It was noted that balloon was not in a stent when it ruptured.The device will not be returned for evaluation as multiple attempts were made without success.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, h1, h2, h3 and h6 as reported, the balloon of a saber 3mm x 15cm 150 ruptured below rbp during the operation.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop or while removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks, or any other damages noted to the device prior to inserting into the patient.The device was prepped per the ifu.The intended procedure was to dilate the lesion which had a stenosis.There was no resistance/friction experienced while inserting the balloon catheter through the rotating hemostatic valve or through the guide catheter.The catheter advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend or was never kinked while being used.The inflation device used was used successfully with other devices.The product was removed from the patient intact (in one piece).It was noted that balloon was not in a stent when it ruptured.The device was not returned for evaluation after multiple attempts were made without success.A product history record (phr) review of lot 82233451 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon- burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of stenosis likely contributed to the reported event, as damage balloon material may have occurred during crossing or upon inflation.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and event reported.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and h6.As reported, the balloon of a saber 3mm 15cm 150 ruptured below rbp during the operation.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop or while removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks, or any other damages noted to the device prior to inserting into the patient.The device was prepped per the ifu.The intended procedure was to dilate the lesion which had a stenosis.There was no resistance/friction experienced while inserting the balloon catheter through the rotating hemostatic valve or through the guide catheter.The catheter advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend or was never kinked while being used.The inflation device used was used successfully with other devices.The product was removed from the patient intact (in one piece).It was noted that balloon was not in a stent when it ruptured.The product was returned for analysis.A non-sterile saber 3mm x 15cm 150 unit was received for analysis inside a plastic bag.Per visual analysis, neither burst, nor rupture or any damage that could cause the reported failure could be observed.Functional test was successfully performed on the received saber unit.A lab sample inflator/ deflator device partially filled with water was attached to the inflation lumen of the unit and positive pressure was applied.The balloon was instantly inflated.Next, negative pressure was also applied, and the saber was immediately deflated as expected.No anomalies found.Neither dimensional analysis, nor microscopic analysis were performed due to no anomalies found on the unit received for evaluation.A product history record (phr) review of lot 82233451 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst at/below rbp¿ was not confirmed through analysis of the returned device.The exact cause of the reported event could not be determined as the device passed functional analysis.The balloon was inflated with no burst or leaks noted and without any issues to the balloon.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as no anomalies were noted on the device.According to the warnings in the safety information in the instructions for use ¿the balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

Event Description

As reported, the balloon of a saber 3mm 15cm 150 ruptured below rbp during the operation.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop or while removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks, or any other damages noted to the device prior to inserting into the patient.The device was prepped per the ifu.The intended procedure was to dilate the lesion which had a stenosis.There was no resistance/friction experienced while inserting the balloon catheter through the rotating hemostatic valve or through the guide catheter.The catheter advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend or was never kinked while being used.The inflation device used was used successfully with other devices.The product was removed from the patient intact (in one piece).It was noted that balloon was not in a stent when it ruptured.The device was returned for evaluation.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a saber 3mm 15cm 150 ruptured below rbp during the operation.There was no reported injury to the patient.The product was stored properly according to the instructions for use (ifu).There was no difficulty removing the product from the hoop or while removing the protective balloon cover.There was no difficulty removing the stylet or any of the sterile packaging components.There were no kinks, or any other damages noted to the device prior to inserting into the patient.The device was prepped per the ifu.The intended procedure was to dilate the lesion which had a stenosis.There was no resistance/friction experienced while inserting the balloon catheter through the rotating hemostatic valve or through the guide catheter.The catheter advanced through the vessel without difficulty.There was no difficulty crossing the lesion.The catheter was never in an acute bend or was never kinked while being used.The inflation device used was used successfully with other devices.The product was removed from the patient intact (in one piece).It was noted that balloon was not in a stent when it ruptured.The device was returned for evaluation.

• Brand Name: SABER 3MM15CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14141118
• MDR Text Key: 289695503
• Report Number: 9616099-2022-05555
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069103
• UDI-Public: (01)20705032069103(17)240930(10)82233451
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48003015X
• Device Catalogue Number: 48003015X
• Device Lot Number: 82233451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 67 KG