MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM10CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006010L

Device Problem Burst Container or Vessel (1074)

Patient Problem Stenosis (2263)

Event Date 07/27/2021

Event Type  malfunction  

Manufacturer Narrative

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 6mm 10cm 155 saber rx percutaneous transluminal angioplasty (pta) balloon catheter was inserted and inflated but it ruptured at 8 atmospheres (atm) during its initial inflation.Therefore, the device was replaced with another non-cordis balloon catheter and it inflated successfully.The procedure was completed with a non-cordis drug-coated balloon catheter.There was no reported patient injury.The lesion was 90 % stenosis of the superficial femoral artery.A contralateral approach was made.A 6f non-cordis sheath was used.An unknown 0.014 guidewire crossed the lesion.The device will not be returned for analysis because it was discarded at the hospital.

Manufacturer Narrative

As reported, the 6mm 10cm 155 saber rx percutaneous transluminal angioplasty (pta) balloon catheter was inserted and inflated but it ruptured at eight atmospheres (atm) during its initial inflation.Therefore, the device was replaced with another non-cordis balloon catheter and it inflated successfully.The lesion had 90 % stenosis of the superficial femoral artery.A contralateral approach was made.A 6f non-cordis sheath was used.An unknown 0.014 guidewire crossed the lesion.The procedure was completed with a non-cordis drug-coated balloon catheter.There was no reported patient injury.The device was not returned for analysis as it was discarded at the hospital.A product history record (phr) review of lot 82191520 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.Procedural factors and vessel characteristics of 90% stenosis likely contributed to the reported event.However, 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 safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.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.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ 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 RX6MM10CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12345197
• MDR Text Key: 268706406
• Report Number: 9616099-2021-04798
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 51006010L
• Device Catalogue Number: 51006010L
• Device Lot Number: 82191520
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (0.014; SHEATH (6FR DESTINATION, TERUMO