MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX 2MM10CM 155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51002010L

Device Problem Burst Container or Vessel (1074)

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

Event Date 05/27/2022

Event Type  malfunction  

Event Description

As reported, the 2mm x 10cm x 155 saber rx percutaneous transluminal angioplasty dilatation catheter ruptured at its nominal pressure.It was replaced with another unknown different-sized device and the procedure continued.There were no reports of patient injury.Multiple attempts were made without success to obtain the device and additional information.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82185348 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.

Manufacturer Narrative

As reported, the 2mm x 10cm x 155 saber rx percutaneous transluminal angioplasty dilatation catheter ruptured at its nominal pressure.It was replaced with another unknown different-sized device and the procedure continued.There were no reports of patient injury.Multiple attempts were made without success to obtain the device and additional information.The product was not returned for analysis.A product history record (phr) review of lot 82185348 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, although unknown and procedural factors likely contributed to the reported event.However, with the limited amount of information available regarding lesion characteristics and without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the 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.

Event Description

As reported, the 2mm x 10cm x 155 saber rx percutaneous transluminal angioplasty dilatation catheter ruptured at its nominal pressure.It was replaced with another unknown different-sized device and the procedure continued.There were no reports of patient injury.Multiple attempts were made without success to obtain the device and additional information.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 2mm x 10cm x 155 saber rx percutaneous transluminal angioplasty dilatation catheter ruptured at its nominal pressure.It was replaced with another unknown different-sized device and the procedure continued.There were no reports of patient injury.Multiple attempts were made without success to obtain the device and additional information.

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 2mm x 10cm x 155 saber rx percutaneous transluminal angioplasty dilatation catheter ruptured at its nominal pressure.It was replaced with another unknown different-sized device and the procedure continued.There were no reports of patient injury.Multiple attempts were made without success to obtain the device and additional information.The device was returned for analysis.A non-sterile saber rx 2mm10cm 155 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a clear plastic bag.Per visual analysis, the balloon profile was inspected, and it appears to have been previously inflated.Dried blood residues were observed on the unit.No other anomalies on the balloon were noted by the naked eye.Per functional analysis, inflation/deflation testing was performed.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 successfully inflated.However, a leakage was observed in the body shaft area of the unit near the balloon proximal seal.Per microscopic analysis, the unit was sent to sem analysis to identify the possible root cause of the torn body shaft.Results showed the saber rx 2mm10cm 155 presented evidence of a ruptured condition and scratch marks near the damaged area.This type of damage is commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the surface probably led to the damaged condition found on the received device.It seems the material near the damage was ruptured with a sharp object from the outside of the device.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 82185348 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 as the balloon inflated without difficulty; however, subsequent findings of a torn body shaft was noted as leakage from the torn area on the shaft was observed.Device analysis revealed a rupture and scratch marks adjacent to the damaged area that most likely led to the ruptured condition found on the received device.Based on the information provided it appears the leakage/rupture was caused by the interaction of the shaft material with a sharp object.It is likely vessel characteristics, although unknown, may have contributed to the reported event as calcified spicules may have damaged the catheter material as evidenced by sem analysis.According to the instructions for use, which are not intended to mitigate risk, ¿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.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.¿ 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 2mm x 10cm x 155 saber rx percutaneous transluminal angioplasty dilatation catheter ruptured at its nominal pressure.It was replaced with another unknown different-sized device and the procedure continued.There were no reports of patient injury.Multiple attempts were made without success to obtain additional information.The device was returned for evaluation.

• Brand Name: SABER RX 2MM10CM 155
• 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: 14808078
• MDR Text Key: 300795772
• Report Number: 9616099-2022-05754
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032075579
• UDI-Public: (01)20705032075579(17)221231(10)82185348
• 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,Followup,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 51002010L
• Device Catalogue Number: 51002010L
• Device Lot Number: 82185348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 06/24/2022; 06/24/2022; 08/26/2022
• Supplement Dates FDA Received: 06/30/2022; 08/02/2022; 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2020
• 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: UNK DEVICE