MAUDE Adverse Event Report: CORDIS CORPORATION SLALOM PTA .018 HP 40 4X4 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 4394040T

Device Problem Burst Container or Vessel (1074)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82220387 presented no issues during the manufacturing process that can be related to the reported event. The device was not returned for analysis. A device history record (dhr) review was performed and showed that these lots of products met all the requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during the percutaneous transluminal angioplasty (pta) of a shunt, the balloon of a slalom thrill. 018 hp 40 4x4 pta balloon catheter ruptured at approximately 6 atmospheres (atm). The slalom thrill pta balloon catheter was removed, and a different size slalom thrill pta was used successfully to complete the procedure. There was no reported injury to the patient. Additional information was requested, but due to covid 19, the information was not able to be obtained and the device will not be returned.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82220387 presented no issues during the manufacturing process that can be related to the reported event. The device was not returned for analysis. A device history record (dhr) review was performed and showed that these lots of products met all the requirements per the applicable manufacturing quality plan. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, during the percutaneous transluminal angioplasty (pta) of a shunt, the balloon of a slalom thrill. 018 hp 40 4x4 pta balloon catheter ruptured at approximately 6 atmospheres (atm). The slalom thrill pta balloon catheter was removed, and a different size slalom thrill pta was used successfully to complete the procedure. There was no reported injury to the patient. Additional information was requested, but due to covid 19, the information was not able to be obtained and the device will not be returned.

• Brand Name: SLALOM PTA .018 HP 40 4X4
• 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: 13119031
• MDR Text Key: 286022329
• Report Number: 9616099-2021-05240
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 4394040T
• Device Lot Number: 82220387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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: 12/30/2021 Patient Sequence Number: 1

Treatment

SLALOM THRILL PTA BALLOON CATHETER