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

Catalog Number	U357574
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2016
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, the pta balloon allegedly detached from the main catheter.Reportedly, the health care provider was able to retrieve the detached segment from the patient without incident.There was no reported retraction difficulties.There was no report of 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 entire catheter, hub proximal portion of balloon, and a majority of the inner polyimide (with proximal marker band intact).The second segment contained the distal tip, distal portion of balloon (bunched) and 1.4 cm of inner polyimide (with distal marker band intact).No ruptures identified on the balloon.No other anomalies were observed to the device.Functional/performance evaluation: no further functional testing could be completed due to the detached balloon.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 balloon detachment based on the condition of the returned sample (i.E.Balloon returned detached).The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.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 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 detached from the main catheter.Reportedly, the health care provider was able to retrieve the detached segment from the patient without incident.There was no reported retraction difficulties.There was no report of 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: 6051518
• Report Number: 2020394-2016-00990
• Device Sequence Number: 16360909
• Product Code: LIT
• UDI-Device Identifier: 00801741093456
• UDI-Public: (01)00801741093456(17)180930(10)50130639
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2016

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: No Information
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: U357574
• Device Lot Number: 50130639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2016
• Supplement Report FDA Received Date: 01/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1