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

Model Number	U3513074
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A lot history review could not be performed as the lot number was not provided.The return of the sample is pending, the company is still investigating the issue at this time.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of reported information indicates that model u3513074, pta balloon dilatation catheter, allegedly experienced a break.This information was received from a single source.This malfunction involved a 64 year old male patient with no consequences.The patient's weight was not provided.
Additional Manufacturer Narrative
H10: a lot history review could not be performed as the lot number was not provided.The sample was not returned for evaluation.The reported failure was inconclusive for the device as no objective evidence was provided.A definitive root cause has not been determined.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of reported information indicates that model u3513074, pta baloon dilatation catheter, allegedly experienced a break.This information was recieved from a single source.This malfunction involved a 64 year old male patient with no consequences.The patient's weight was not provided.

• 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: 9965348
• Report Number: 2020394-2020-02791
• Device Sequence Number: 2749713
• Product Code: LIT
• UDI-Device Identifier: 00801741093678
• UDI-Public: (01)00801741093678
• 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): 07/02/2020

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: U3513074
• Device Catalogue Number: U3513074
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/02/2020
• Patient Sequence Number: 1