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

Model Number	V186040
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The device was returned for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model v186040 vascutrak pta dilatation catheter allegedly experienced material deformation (kink) and difficult to insert issues.This information was received from one source.Of the one malfunction, one patient was involved with no patient consequence or impact.Patient's age, weight, and gender was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model v186040 vascutrack pta dilatation catheter allegedly experienced material deformation (kink) and difficult to insert issues.This information was received from one source.Of the one malfunction, one patient was involved with no patient consequence or impact.Patient's age, weight, and gender was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The device was returned for evaluation and material deformation was identified.A root cause could not be determined.The device is 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.

• Brand Name: VASCUTRACK 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: 9594171
• Report Number: 2020394-2020-00419
• Device Sequence Number: 328059
• Product Code: PNO
• UDI-Device Identifier: 00801741061752
• UDI-Public: (01)00801741061752
• 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): 04/02/2020

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: V186040
• Device Catalogue Number: V186040
• Device Lot Number: GFBN1217
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1