MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SLEEK PTA DILATATION CATHETER

Model Number	425-2522X
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device will be returned to bd for evaluation.The return of the device is still pending.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 425-2522x pta balloon dilatation catheter experienced a material rupture.This report was received from one source.This event involved one patient with no patient consequences.The patient¿s age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided and a lot history review was performed.The result of the investigation is confirmed for the reported catheter rupture failure mode issue.The definitive root cause for the reported catheter rupture failure mode issue could not be determined based upon available information.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 event.A review of the event indicated that model 425-2522x pta balloon dilatation catheter experienced a material rupture.This report was received from one source.This event involved one patient with no patient consequences.The patient¿s age, weight, and gender were not provided.

• Brand Name: SLEEK PTA DILATATION CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8533001
• Report Number: 9616666-2019-00046
• Device Sequence Number: 19201008
• Product Code: LIT
• UDI-Device Identifier: 00801741132407
• UDI-Public: (01)00801741132407
• 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): 07/23/2019

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: 425-2522X
• Device Catalogue Number: 425-2522X
• Device Lot Number: CMCX0021
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1