MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE DILATATION CATHETER; VALVULOPLASTY BALLOON CATHETER

Model Number 0244512

Device Problems Break (1069); Deflation Problem (1149); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the reported break, leak, deflation problem, retraction problem, inflation problem and material rupture.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 0244512 valvuloplasty balloon catheter allegedly break, leak, deflation problem, retraction problem, inflation problem, and material rupture.The information was received from a single source.This malfunction involved one patient with no patient consequences.A (b)(6)years old male patient weighs(b)(6) lbs.

• Brand Name: TRUE DILATATION CATHETER
• Type of Device: VALVULOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10735961
• MDR Text Key: 213082156
• Report Number: 2020394-2020-06069
• Device Sequence Number: 1
• Product Code: OZT
• UDI-Device Identifier: 00801741091018
• UDI-Public: (01)00801741091018
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0244512
• Device Catalogue Number: 0244512
• Device Lot Number: GFCN2373
• Date Manufacturer Received: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1