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

Model Number	0264513
Medical Device Problem Codes	Leak/Splash (1354); 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 not provided so a lot history review could not be performed.The device was returned to bd for evaluation.The investigation identified for material rupture.Based on the information provided, the definitive root cause in 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 model 0264513 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.This malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was not provided so a lot history review could not be performed.The device was returned to bd for evaluation.The investigation identified for leak.Based on the information provided, the definitive root cause in unknown.However, the reported malfunction has been reassessed for reportability and determined to be no longer reportable.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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0264513 pta balloon dilatation catheter allegedly experienced material rupture.This information was received from one source.This malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.

• Brand Name: TRUE 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: 9572519
• Report Number: 2020394-2020-00186
• Device Sequence Number: 3079924
• Product Code: OZT
• UDI-Device Identifier: 00801741096631
• UDI-Public: (01)00801741096631
• 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): 03/30/2020

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: 0264513
• Device Catalogue Number: 0264513
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1