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

Model Number	U357568
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(expiry date: 06/2023).
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had balloon rupture.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly had balloon rupture.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one ultraverse 035 pta dilatation catheter was returned for the evaluation.Visual evaluation was performed and noted that device appeared to be bloody.No anomalies were noted to the device.During the functional testing, an in house presto inflation device was used to inflate the balloon and observed that no water was exiting from the balloon.No other functional testing was performed.Therefore, the investigation is unconfirmed for the reported balloon rupture, as no water exiting from the balloon during the functional test.A definitive root cause for the alleged balloon rupture could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 06/2023).H11:section a through f - the information provided by bd 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 bd.H3 other text : see h10.

• Brand Name: ULTRAVERSE 035 PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DIALATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11691595
• Report Number: 2020394-2021-00882
• Device Sequence Number: 19701428
• Product Code: LIT
• UDI-Device Identifier: 00801741092978
• UDI-Public: (01)00801741092978
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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 Model Number: U357568
• Device Catalogue Number: U357568
• Device Lot Number: CMEU0272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other