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

Catalog Number	VA8086R
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2017
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 device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 retraction of a pta balloon catheter through a 7 fr sheath, the balloon allegedly got stuck inside the sheath and detached.Reportedly, the sheath was removed with the detached balloon and another sheath was inserted and the procedure was completed with a new balloon.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.Conclusion: the device was returned.A visual inspection found a complete detachment of the outer catheter just proximal to the proximal balloon glue joint.The proximal balloon glue joint was intact.Also the inner guidewire lumen was found to be detached, near the distal tip.Therefore, the investigation is unconfirmed for the reported balloon detachment, and is confirmed for a catheter detachment.The balloon was found to be partially prolapsed over the distal tip.Therefore, the investigation is confirmed for sheath related retraction issues.It is likely that retraction issues contributed to the identified catheter detachment.However, the definitive root cause for the retraction issues could not be determined based upon the available information.Labeling review: the current ifu (instructions for use) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip breakage or balloon separation.Do not exceed the rbp recommended for this device.Balloon rupture may occur if the rbp rating is exceeded.To prevent over pressurization, use of a pressure monitoring device is recommended.Precautions: if resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit.Potential adverse reactions:.
Event or Problem Description
It was reported that during retraction of a pta balloon catheter through a 7 fr sheath, the balloon allegedly got stuck inside the sheath and detached.Reportedly, the sheath was removed with the detached balloon and another sheath was inserted and the procedure was completed with a new balloon.There was no reported patient injury.

• Brand Name: VACCESS PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6846832
• Report Number: 2020394-2017-01083
• Device Sequence Number: 44486
• Product Code: DQY
• UDI-Device Identifier: 00801741059964
• UDI-Public: (01)00801741059964
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 05/02/2020
• Device Catalogue Number: VA8086R
• Device Lot Number: 93QB0216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 61