MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U41502H22
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.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.
Event or Problem Description
This report summarizes one(1) malfunction event.A review of the event indicated that model u41502h22 pta dilatation catheter allegedly experienced the outer layer of the balloon peeling after removing the balloon from a hep-saline bowl.The procedure was completed with another balloon.This report was received from one source.This event involved one patient whose age, weight and gender were not provided.There was no patient contact.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model u41502h22 pta dilatation catheter allegedly experienced the outer layer of the balloon peeling after removing the balloon from a hep-saline bowl.The procedure was completed with another balloon.This report was received from one source.This event involved one patient whose age, weight and gender were not provided.There was no patient contact.
Additional Manufacturer Narrative
H10: the lot number was provided for the single returned device and a lot history review was performed.A longitudinal rupture was noted on distal cone of the balloon on the device.A root cause has not been determined.The device was labeled for single use.H11: h6 (device code 2, results 1, conclusion 1).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 014 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: 8528125
• Report Number: 2020394-2019-00487
• Device Sequence Number: 19522725
• Product Code: LIT
• UDI-Device Identifier: 00801741053658
• UDI-Public: (01)00801741053658
• 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: U41502H22
• Device Catalogue Number: U41502H22
• Device Lot Number: CMCY0142
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1