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

Model Number	V184040
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and a lot history review will be performed.The device was not returned for evaluation, therefore the investigation is inconclusive for the reported failure as no objective evidence was provided.The definitive root cause could not be established.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model v184040 pta balloon dilatation catheter allegedly experienced a break.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.One device was returned for the reported malfunction.The definitive root cause could not be established.The investigation is confirmed for detachment of device or device component.A root cause could not be determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model v184040 pta balloon dilatation catheter allegedly experienced a break and detachment of device or device component.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.

• Brand Name: VASCUTRAK 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: 9211273
• Report Number: 2020394-2019-04104
• Device Sequence Number: 18934862
• Product Code: PNO
• UDI-Device Identifier: 00801741061530
• UDI-Public: (01)00801741061530
• 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): 01/17/2020

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
• Operator of Device: No Information
• Device Model Number: V184040
• Device Catalogue Number: V184040
• Device Lot Number: GFCV1522
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/17/2020
• Patient Sequence Number: 1