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

Model Number	U357564
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device was returned for evaluation.Received one 035 ultraverse catheter; device was returned in two segments.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.A review of the reported information indicated that the catheter shaft of a model u357564 pta balloon dilatation catheter allegedly broke and detached.This information was received from a single source.The alleged malfunction did not involve a patient as there was no patient contact.The patient age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that the catheter shaft of a model u357564 pta balloon dilatation catheter allegedly broke and detached.This information was received from a single source.The alleged malfunction did not involve a patient as there was no patient contact.The patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device was returned for evaluation.The investigation is confirmed for the reported catheter shaft detachment.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.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 035 PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8811846
• Report Number: 2020394-2019-01654
• Device Sequence Number: 19461406
• 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): 10/23/2019

1 Device 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: CMDN0398
• 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: 10/23/2019