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

Catalog Number	V1860300
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during an angioplasty procedure, the inflation hub of the pta balloon allegedly detached.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the inflation hub to be detached from the rest of the catheter.Therefore, the investigation is confirmed for a hub detachment.The definitive root cause for the hub detachment could not be determined based upon the available information.It is unlikely that the event is manufacturing related, as a each lot undergoes a 100% leak test, a visual inspection of the hub bond, and 100% line clearance during the assembly process.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: g4, h6 (trending device code: replaced 1069 - break with 2907 - detachment of device or device component).
Event or Problem Description
It was reported that during an angioplasty procedure, the inflation hub of the pta balloon allegedly detached.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: VASKUTRAK 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: 8005932
• Report Number: 2020394-2018-01935
• Device Sequence Number: 1311335
• Product Code: PNO
• UDI-Device Identifier: 00801741061837
• UDI-Public: (01)00801741061837
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K103459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: Health Professional
• Device Expiration Date: 11/28/2020
• Device Catalogue Number: V1860300
• Device Lot Number: GFBY1899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1