MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER

Catalog Number	U357554
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2016
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 has been returned for evaluation.The investigation 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 an angioplasty procedure an alleged leak was observed at the strain relief of the device post inflation.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The lot met all release criteria.Visual inspection: the balloon appeared to have been previously inflated.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 5mm x 40mm balloon.No anomalies were noted to the strain relief or the y-hub.Functional/performance/microscopic evaluation: the patency was tested using an in-house.035¿ guidewire and passed without issue.The strain relief was removed from the y-hub and a partial circumferential catheter shaft break was noted near the distal end of the y-hub.The catheter break was examined under microscopic magnification (10x) and the edges of the break were jagged.No sanding marks were identified near the break or past the hub.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the device was returned.The investigation is confirmed for a partial circumferential catheter shaft break just distal to the y-hub, resulting in the reported leak.A partial circumferential break was found near the hub.It is unknown whether handling techniques by the user as they removed the catheter from the packaging or prepped the device may have contributed to the reported issue.Based upon the available information a definitive root cause has not been determined.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 or catheter breakage, catheter kink, or balloon separation.Precautions: - if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath/guide catheter, determine if contrast is trapped in the balloon with fluoroscopy.If contrast is present, push the balloon out of the introducer sheath/guide catheter and then completely evacuate the contrast before proceeding to withdraw the balloon.- if resistance is still felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and introducer sheath/guide catheter as a single unit.Potential adverse reactions the complications that may result from a peripheral balloon dilatation procedure include: - additional intervention use of ultraverse 035 pta dilatation catheter: - apply negative pressure to fully evacuate fluid from the balloon.Confirm that the balloon is fully deflated under fluoroscopy and that no contrast is left in the balloon.- while maintaining negative pressure and the position of the guidewire, grasp the balloon catheter just outside the introducer sheath/guide catheter and withdraw the deflated dilatation catheter over the wire through the introducer sheath/guide catheter.Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath/guide catheter.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 an alleged leak was observed at the strain relief of the device post inflation.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: ULTRAVERSE 035 PTA BALLOON 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: 6301533
• Report Number: 2020394-2017-00038
• Device Sequence Number: 18967887
• Product Code: LIT
• UDI-Device Identifier: 00801741092459
• UDI-Public: (01)00801741092459(17)190630(10)CMAU0072
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2016

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: 06/30/2019
• Device Catalogue Number: U357554
• Device Lot Number: CMAU0072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1