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 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available. A review of the manufacturing documentation associated with this lot#: 82193162 presented no issues during the manufacturing process that can be related to the reported complaint. However, it will be submitted within 30 days upon receipt.

Event Description

After implantation of an unknown stent, a 6mm x 10cm x 155cm saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter was inflated again, however, it ruptured. The balloon burst at approximate 8 atm. Initially, after a wire crossed a 20cm lesion, a saber pta balloon was used and inflated two times. There was no reported patient injury. The target lesion was the superficial femoral artery (sfa) with stenosis. A contralateral approach was made. There was no difficulty removing the product from the hoop or when removing the protective balloon cover. There was no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. The device was prep normally. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or when inserting the balloon through the guide catheter. The device will be returned for evaluation.

• Brand Name: SABER RX6MM10CM155
• 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: 12535985
• MDR Text Key: 274534199
• Report Number: 9616099-2021-04899
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 51006010L
• Device Catalogue Number: 51006010L
• Device Lot Number: 82193162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial