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

Model Number	VA5084
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes four malfunction events.A review of the events indicated that model va5084 pta balloon dilatation catheter experienced retraction problems.These reports were received from various sources.Of the four events, all involved patients with no consequence or impact.None of the patients¿ weights were provided.One patient was (b)(6) years old with the rest did not provide their age.Of the reported patients, one was male and rest were not provided.Three va5084 pta balloon dilatation catheters were returned to the manufacturer and pending investigation.The other event did not return a sample.
Additional Manufacturer Narrative
H10: three of the four reported malfunctions provided a lot number, therefore lot history reviews were performed.Of the four reported malfunctions, three devices were returned.Two devices were confirmed for the reported retraction issues.One device that was returned identified retraction issues as well as a circumferential break.One of the reported malfunctions was inconclusive for the reported retraction issues, as the device was not returned.A definitive root cause could not be established.The devices are 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 or Problem Description
This report summarizes four malfunction events.A review of the events indicated that model va5084 pta balloon dilatation catheter experienced retraction problems.These reports were received from various sources.Of the four events, all involved patients with no consequence or impact.None of the patients¿ weights were provided.One patient was 59 years old with the rest did not provide their age.Of the reported patients, one was male and rest were not provided.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8515087
• Report Number: 2020394-2019-00285
• Device Sequence Number: 2817061
• Product Code: DQY
• UDI-Device Identifier: 00801741059728
• UDI-Public: (01)00801741059728
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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
• Operator of Device: No Information
• Device Model Number: VA5084
• Device Catalogue Number: VA5084
• Device Lot Number: 93XC0153, 93ZC0027, UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1