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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number U357574
Device Problems Balloon; Detachment Of Device Component; Detachment of Device or device Component; Tip
Event Date 11/05/2015
Event Type  Injury  
Manufacturer Narrative

The lot number for the device has been provided. A review of the device history records is currently being performed. The device has not been returned to the manufacturer 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. Device not returned.

 
Event Description

It was reported that the pta balloon catheter allegedly ruptured circumferentially at 6 atm in a left upper arm av graft fistula between the radial artery and axillary vein. It was further reported that the balloon catheter was allegedly difficult to retract from the target site and allegedly resulted in detachment of the distal portion of the balloon and catheter tip. The health care provider (hcp) said that no attempt was made to remove the balloon segment and catheter tip from the graft as they did not want to risk embolization. The procedure was not completed. Reportedly, the patient is doing well.

 
Manufacturer Narrative

Manufacturing review: the lot number was provided and the lot device history records were reviewed. The 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 for this lot number and issue to date. Visual inspection and functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed. Medical records review: medical records were not provided for review. Image/photo review: images/photos were not provided for review. Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation. Per the reported event details, the calcification of the lesion may have contributed to the rupture. The balloon rupture likely contributed to the retraction issues and the balloon detachment. However, based upon the available information the definitive root cause is unknown. 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 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. Equipment for use: luer lock syringe/inflation device with manometer (10 ml or larger). 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.

 
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Brand NameULTRAVERSE 035 PTA BALLOON DILATATION CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI 
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe , AZ 85281
4803032689
MDR Report Key5258970
Report Number2020394-2015-01955
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 11/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device Catalogue NumberU357574
Device LOT Number50125823
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/22/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/15/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/01/2015 Patient Sequence Number: 1
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