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

Model Number	U4150512
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, the device was returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model u4150512 pta balloon dilatation catheter allegedly experienced detachment.This information was received from one source.There was no patient contact.The (b)(6) year old male patient weight was (b)(6) lbs.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review will be performed.The device was returned for evaluation.The investigation is unconfirmed for the reported balloon detachment.A visual inspection also found a break in the outer catheter shaft.Therefore, the investigation is confirmed for the identified break in the outer catheter shaft.The definitive root cause is unknown.The device is labeled for single use.H11: g1, h6 (results, 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.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model u4150512 pta balloon dilatation catheter allegedly experienced detachment.This information was received from one source.There was no patient contact.The 53 year old male patient weight was 312 lbs.

• 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: 8812537
• Report Number: 2020394-2019-01670
• Device Sequence Number: 11407060
• Product Code: LIT
• UDI-Device Identifier: 00801741054198
• UDI-Public: (01)00801741054198
• 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): 10/11/2019

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: U4150512
• Device Catalogue Number: U4150512
• Device Lot Number: CMDQ0595
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/12/2019
• Patient Sequence Number: 1