MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX7MM4CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51007004L

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

As reported, a 7mm x 4cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter was being used for pre-dilation of a calcified iliac lesion when the balloon ruptured.It was reported that other non-cordis balloon catheters used during this procedure had also ruptured.There was no reported injury to the patient.Additional information was requested but was not provided, and the device was discarded and will not be returned.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 7mm x 4cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter was being used for pre-dilation of a severely calcified iliac lesion when the balloon ruptured at 8 atmospheres (atm).It was reported that another non-cordis balloon catheter used during this procedure had also ruptured during an inflation to 6 atm.There was no reported injury to the patient.This was during a procedure to treat an iliac lesion which had severe calcification and severe tortuosity.There was a 99% stenosis of the target vessel; however, the lesion was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.A 1:1 contrast to saline ratio was used to prep the balloon.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the device.The device was able to track toward the lesion without issue; however, there was some difficulty crossing the lesion due to the level of calcification.It was reported that the balloon catheter was put into an acute bend during this procedure but did not kink during its use.The saberx pta balloon catheter was able to be removed easily from the patient, and both the ruptured 7mm x 4cm 155cm saberx pta, and the ruptured non-cordis balloon catheter were removed from the patient in one piece.Information regarding the completion of the procedure, and the existence of additional cordis device malfunctions was requested but was not provided.The device was discarded and will not be returned.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: a2, a3, b3, d4, d10, g3, g4, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, a 7mm x 4cm 155cm saberx percutaneous transluminal angioplasty (pta) balloon catheter was being used for pre-dilation of a severely calcified iliac lesion when the balloon ruptured at eight atmospheres (atm).It was reported that another non-cordis balloon catheter used during this procedure had also ruptured during an inflation to six atm.There was no reported injury to the patient.This was during a procedure to treat an iliac lesion which had severe calcification and severe tortuosity.There was a 99% stenosis of the target vessel; however, the lesion was not a chronic total occlusion (cto).The device was stored and prepped per the instructions for use (ifu) and maintained negative pressure during preparation.A 1:1 contrast to saline ratio was used to prep the balloon.There was no difficulty removing the device from the hoop, removing the protective balloon cover, the stylet, or any of the sterile packaging components and the device was not kinked or damaged in any way prior to being inserted into the patient.There was no resistance or friction experienced during insertion of the device.The device was able to track toward the lesion without issue; however, there was some difficulty crossing the lesion due to the level of calcification.It was reported that the balloon catheter was put into an acute bend during this procedure but did not kink during its use.The saberx pta balloon catheter was able to be removed easily from the patient, and both the ruptured 7mm x 4cm 155cm saberx pta, and the ruptured non-cordis balloon catheter were removed from the patient in one piece.Information regarding the completion of the procedure, and the existence of additional cordis device malfunctions was requested but was not provided.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82216944 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.It was also reported that other non-cordis balloon catheters used during this procedure had also ruptured.Therefore, based on the information available for review, it is likely vessel characteristics of severe calcification and 99% stenosis likely contributed to the reported event, as calcification is known to damage balloon material.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.

• Brand Name: SABER RX7MM4CM155
• 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 32574
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14185676
• MDR Text Key: 290463650
• Report Number: 9616099-2022-05575
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075364
• UDI-Public: (01)20705032075364(17)240229(10)82216944
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 51007004L
• Device Lot Number: 82216944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Date Device Manufactured: 03/23/2021
• 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
• Treatment: BSJ STERLING PTA BALLOON CATHETER; UNK BALLOON CATHETER
• Patient Age: 80 YR
• Patient Sex: Female