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

Catalog Number	VA8064
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly was not able to be retracted through the sheath.Reportedly, a 7fr sheath was used to pull the balloon and original sheath together to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in the cephalic vein of the left forearm, the pta balloon allegedly was not able to be retracted through the sheath.Reportedly, a 6fr sheath was used to pull the balloon and original sheath together as one unit.Another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and 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 a complete cut through the catheter shaft and inner guidewire lumen at the proximal balloon joint.This cut will be considered incidental as the user reported cutting the device to remove it from the sheath.However, no signs of retraction issues were identified on the returned segments, and the user's sheath was not returned for evaluation.Therefore, the investigation is inconclusive for the reported retraction issue.The definitive root cause for the reported retraction issue could not be determined based upon available information.It is unknown whether procedural issues and/or the original sheath used for the procedure 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.

• 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: 7787179
• Report Number: 2020394-2018-01473
• Device Sequence Number: 1986226
• Product Code: DQY
• UDI-Device Identifier: 00801741121296
• UDI-Public: (01)00801741121296
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111850
• 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): 11/16/2018

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: VA8064
• Device Lot Number: 93XB0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1