MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. BARD CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number CQF75104

Device Problem Deflation Problem (1149)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2022

Event Type  Injury  

Event Description

Post angioplasty procedure the balloon would not deflate. The balloon had to be punctured subcutaneously by using a 20-gauge needle. Ref uf (b)(4).

• Brand Name: BARD CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC.; 1625 w. 3rd street; ste 109; tempe AZ 85281
• MDR Report Key: 14052283
• MDR Text Key: 289009483
• Report Number: MW5108826
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CQF75104
• Device Catalogue Number: CQF75104
• Device Lot Number: REEV3410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 04/07/2022 Patient Sequence Number: 1