MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER

Model Number	U41502H10
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned to bd for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model u41502h10 pta balloon dilatation catheter experienced peeled material.This report was received from one source.This event did not involve a patient; therefore, patient identifiers are not required.
Additional Manufacturer Narrative
The device has been returned for evaluation; the investigation is inconclusive for the reported peeling issue as no such failure was identified in sample evaluation.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model u41502h10 pta balloon dilatation catheter experienced peeled material.This report was received from one source.This event did not involve a patient; therefore, patient identifiers are not required.

• Brand Name: ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• MDR Report Key: 8515652
• Report Number: 2020394-2019-00307
• Device Sequence Number: 19245337
• Product Code: LIT
• UDI-Device Identifier: 00801741053566
• UDI-Public: (01)00801741053566
• 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: U41502H10
• Device Catalogue Number: U41502H10
• Device Lot Number: CMCZ0374
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1