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

Model Number	425-2022X
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 device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device has not been returned for evaluation; therefore, the investigation is inconclusive for material rupture as no objective evidence has been provided to confirm any alleged deficiency with the dilatation catheter.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 1 malfunction event.A review of the event indicated that model 425-2022x dilatation catheter experienced a material rupture.This event was reported from a single source.This event involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.

• Brand Name: SLEEK RX 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: 8532928
• Report Number: 9616666-2019-00040
• Device Sequence Number: 13856031
• Product Code: LIT
• UDI-Device Identifier: 00801741132292
• UDI-Public: (01)00801741132292
• 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
• Report Date (Section B): 04/19/2019

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: 425-2022X
• Device Catalogue Number: 425-2022X
• Device Lot Number: 50143957
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1