MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER

Model Number U4200215RX

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/28/2020

Event Type  Malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed. The return of the sample is pending. The investigation of the reported event is currently underway. (expiry date: 06/2021). Device pending return.

Event Description

It was reported that during an angioplasty procedure, the hydrophilic coating on the device allegedly comes off on the gloves. There was no reported patient injury.

• Brand Name: ULTRAVERSE RX PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10893549
• MDR Text Key: 217940424
• Report Number: 2020394-2020-20572
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K131199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,HEALTH

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/30/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/24/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: U4200215RX
• Device Catalogue Number: U4200215RX
• Device LOT Number: CMCU0484
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• 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: 11/24/2020 Patient Sequence Number: 1