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

Model Number	U35130530
Medical Device Problem Codes	Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
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 return of the device is pending.The investigation is currently under way.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 after the first inflation, the pta balloon catheter allegedly would not deflate.It was further reported that the health care provider used an inflation device to over inflate the balloon and cause it to rupture.Reportedly, the balloon catheter was removed without incident.No further treatment was provided.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been 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 event reported to date for this lot number and failure mode.Investigation summary: the device was returned.A visual inspection found a longitudinal rupture extending for the majority of the balloon length.Per the reported event details, the user over-inflated the device to rupture the balloon, as the device allegedly could not be deflated.Therefore, the investigation is confirmed for a use-of-device issue.The investigation is inconclusive for the reported deflation issue, as the device was unable to be functionally tested due to the longitudinal rupture.The definitive root cause for the reported deflation issue could not be determined based upon the available information.Per the reported event details, the user over-inflated the device to rupture the balloon, as the balloon could allegedly not be deflated after dilatation.The current instructions for use states to not exceed the rbp recommended for the device, and to remove the balloon catheter and introducer sheath/guide sheath as a single unit, if resistance is felt during post procedure withdrawal of the device.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 is 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.
Event or Problem Description
It was reported that after the first inflation, the pta balloon catheter allegedly would not deflate.It was further reported that the health care provider used an inflation device to over inflate the balloon and cause it to rupture.Reportedly, the balloon catheter was removed without incident.No further treatment was provided.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: 7301092
• Report Number: 2020394-2018-00165
• Device Sequence Number: 13755962
• Product Code: LIT
• UDI-Device Identifier: 00801741092756
• UDI-Public: (01)00801741092756
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

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: 10/31/2020
• Device Model Number: U35130530
• Device Catalogue Number: U35130530
• Device Lot Number: CMBY0109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Supplement Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 81