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

Model Number	U357564
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and a lot history review will be performed.The sample was returned for evaluation.The company is still investigating the issue at this time.The device was labeled for single use.
Event or Problem Description
This information summarizes one malfunction.A review of reported information indicates that model u357564, pta balloon dilatation catheter, allegedly experienced material rupture.This information was received from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not reported.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The sample was returned for evaluation.The investigation is unconfirmed for balloon rupture and confirmed for lumen tear.The definitive root cause could not be determined.The device was labeled for single use.H10: h6 (device: 4008).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 information summarizes one malfunction.A review of reported information indicates that model u357564, pta balloon dilatation catheter, allegedly experienced material rupture.This information was recieved from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not reported.

• 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: 9964570
• Report Number: 2020394-2020-02743
• Device Sequence Number: 11399700
• 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): 07/02/2020

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: U357564
• Device Catalogue Number: U357564
• Device Lot Number: CMDS0527
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/02/2020
• Patient Sequence Number: 1