MAUDE Adverse Event Report: CORDIS CORPORATION SABER RX6MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006004L

Device Problem Burst Container or Vessel (1074)

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

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, a 6mm4cm155 saber rx percutaneous transluminal angioplasty (pta) ruptured around rated balloon pressure. There was no reported patient injury. The device was replaced with another unknown balloon catheter and the procedure was completed. The lesion was the iliac artery. The device will not be returned for evaluation as it was discarded. Additional information was requested; however, the information could not obtained.

• Brand Name: SABER RX6MM4CM155
• 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: 14255829
• MDR Text Key: 290446418
• Report Number: 9616099-2022-05601
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 51006004L
• Device Catalogue Number: 51006004L
• Device Lot Number: 82183359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 12/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/29/2022 Patient Sequence Number: 1

Treatment

UNK BALLOON CATHETER.