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

Model Number	U357564
Medical Device Problem Codes	Break (1069); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the one reported event, the one device was returned to bd and evaluated.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model u357564 pta balloon dilatation catheter allegedly ruptured circumferentially.This report was received from one source.Of the one event, did involve patient with no reported patient injury.The patients' age ranged from (b)(6), weight was (b)(6).Of the reported patients, one was male.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model u357564 pta balloon dilatation catheter allegedly ruptured circumferentially.These report was received from one source.Of the one event, did involved patient with no reported patient injury.The patients' age ranged from 74 years, weight was 161 lbs.Of the reported patients, one was male.
Additional Manufacturer Narrative
H10: the device(s) has been returned for evaluation; the investigation is confirmed for retraction problem and break.However, the investigation is inconclusive for the reported material rupture as no circumferential rupture was identified on the sample.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: h6(method, 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.

• Brand Name: ULTRAVERSE 035 PTA 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: 8518817
• Report Number: 2020394-2019-00332
• Device Sequence Number: 13933140
• Product Code: LIT
• UDI-Device Identifier: 00801741092954
• UDI-Public: (01)00801741092954
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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 Model Number: U357564
• Device Catalogue Number: U357564
• Device Lot Number: CMCW0265
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1