MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VACCESS PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number VA80104

Device Problems Deflation Problem (1149); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided; therefore, a lot history review was performed.For the two malfunctions samples were returned, and the investigation is confirmed for the reported deflation problem and retraction problem.A definite root cause for the reported event could not be determined.The device was labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model va80104 pta balloon dilatation catheter allegedly experienced deflation problem and retraction problem.This information was received from one source.This malfunction involved one patient with no consequences.The weight of (b)(6) year old male is (b)(6) pounds.

Manufacturer Narrative

H10: the lot number was provided; therefore, a lot history review was performed.For the two malfunctions samples were returned, and the investigation is confirmed for the reported retraction problem and inconclusive for the reported deflation problem.A definite root cause for the reported event could not be determined.The device was labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes two malfunctions.A review of the reported information indicated that model va80104 pta balloon dilatation catheter allegedly experienced deflation problem and retraction problem.This information was received from one source.This malfunction involved one patient with no consequences.The weight of 64 year old male is 170 pounds.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10308244
• MDR Text Key: 199885860
• Report Number: 2020394-2020-04897
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741121258
• UDI-Public: (01)00801741121258
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VA80104
• Device Catalogue Number: VA80104
• Device Lot Number: 93NE0032
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/27/2020
• Patient Sequence Number: 1