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

Catalog Number	V186040
Medical Device Problem Codes	Retraction Problem (1536); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
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.Expiry date: 05/2021.
Event or Problem Description
It was reported that during an angioplasty procedure in the sfa the scoring wire of the pta balloon allegedly kinked during the second inflation attempt.It was further reported that there was resistance removing the guidewire from the balloon.Reportedly, there was difficulty retracting the balloon through the sheath.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the sfa the scoring wire of the pta balloon allegedly kinked during the second inflation attempt.It was further reported that there was resistance removing the guidewire from the balloon.Reportedly, there was difficulty retracting the balloon through the sheath.The procedure was concluded, and no further treatment was provided.There was no reported patient injury.
Additional Manufacturer Narrative
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 outer scoring wire to be kinked, therefore the investigation is confirmed for the reported kink.However, due to dried blood in the rapid exchange lumen the in-house guidewire was not able to be inserted fully.Therefore, the investigation is inconclusive for the reported guidewire incompatibility issue.And the investigation is inconclusive for the reported sheath related retraction issues as the device was unable to be fully functionally tested due to the kink in the scoring wire.The definitive root cause for the identified kink or reported issues could not be determined based upon available information.It is unknown whether patient and/or procedural issues or the original guidewire and sheath contributed to the event.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: d4 - expiry date: 05/2021.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: 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: 8144319
• Report Number: 2020394-2018-02178
• Device Sequence Number: 1887948
• Product Code: PNO
• UDI-Device Identifier: 00801741061752
• UDI-Public: (01)00801741061752
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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 Catalogue Number: V186040
• Device Lot Number: GFCS3350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1