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

Catalog Number	U357574
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2016
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.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 in the basilic vein the pta balloon allegedly ruptured circumferentially at 20 atm during the first inflation.Reportedly, there was difficulty retracting the balloon through the 6fr sheath.The pta balloon was exchanged over the guidewire for another that 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/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 7mm x 40mm balloon.The first segment contained the hubs, shaft, and the proximal base of the balloon.A complete compound rupture was observed.The second segment contains the distal tip, distal marker band, an accordioned portion of inner polyimide and distal portion of the balloon.The edges of the rupture and the inner catheter detachment were examined under microscopic magnification and were observed to be jagged.The proximal marker band was detached and not returned with the device.No other anomalies were noted to the returned device.Functional/performance evaluation: no functional testing could be performed due to the condition in which the sample was returned (i.E.Balloon detachment).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 complete circumferential balloon rupture, balloon detachment and marker band detachment based upon the condition in which the sample was received.The investigation is inconclusive for sheath related retraction issues, as the sample was returned in poor condition and functional testing could not be performed.Per the reported event details, the balloon ruptured at 20atm.The rated burst pressure (rbp) for this balloon size is 14atm; therefore, the balloon was overpressurized.It is likely the balloon rupture led to the retraction issues and balloon detachment.The root cause for this event is use-related.Labeling review: the current ifu (instructions for use) states: warnings: 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 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.Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.Potential adverse reactions: additional intervention.(b)(4).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 in the basilic vein the pta balloon allegedly ruptured circumferentially at 20 atm during the first inflation.Reportedly, there was difficulty retracting the balloon through the 6fr sheath.The pta balloon was exchanged over the guidewire for another that 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: 6156518
• Report Number: 2020394-2016-01143
• Device Sequence Number: 10942917
• Product Code: LIT
• UDI-Device Identifier: 00801741093456
• UDI-Public: (01)00801741093456(17)190930(10)CMAX0044
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2016

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: 09/30/2019
• Device Catalogue Number: U357574
• Device Lot Number: CMAX0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2016
• Supplement Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1