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

Model Number	U4150315RX
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
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.The investigation of the reported event is currently underway.(expiry date: 02/2022).
Event or Problem Description
It was reported that during an angioplasty procedure of highly calcified lesion, the pta balloon allegedly ruptured at about 10 atm.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one ultraverse rx pta dilatation catheter was returned for the evaluation.Visual evaluation was performed and noted that device appeared to be clean.Device returned into two segments, one segment contains the inflation hub connected to a 3 way- valve and second segment contains balloon with remaining portion of the catheter.Functional test was not performed due to the condition of the device.Therefore, the investigation is confirmed for the identified detachment issue, as device returned into two segments.The investigation is inconclusive for the reported balloon rupture as functional test was not performed due to condition of the device.A definitive root cause for the balloon rupture and detachment issue 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: 02/2022),g3,h6(method) h11: h6(result, conclusion) 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.See h10.
Event or Problem Description
It was reported that during an angioplasty procedure of highly calcified lesion, the pta balloon allegedly ruptured at about 10 atm.There was no reported patient injury.

• Brand Name: ULTRAVERSE RX PTA 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: 11847045
• Report Number: 2020394-2021-01064
• Device Sequence Number: 14394439
• Product Code: LIT
• UDI-Device Identifier: 00801741056956
• UDI-Public: (01)00801741056956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: U4150315RX
• Device Catalogue Number: U4150315RX
• Device Lot Number: CMDQ0320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 04/24/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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