MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SAVVY LONG OTW PTA CATHETER; PTA DILATATION CATHETER

Model Number	436-2515L
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.This is the only complaint reported to date for this lot number and failure mode.The result of the investigation is inconclusive for the reported catheter rupture failure mode issue.The device was not returned for evaluation.The definitive root cause for the reported catheter rupture failure mode issue could not be determined based upon available information.It is unknown if handling or procedural techniques were factors to the reported issue.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the events indicated that model 436-2515l pta dilatation catheter, allegedly experienced a rupture.This report was received from one source.This event involved one patient whose age, weight and gender was not provided.This patient had no reported patient injury.

• Brand Name: SAVVY LONG OTW PTA CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8532923
• Report Number: 9616666-2019-00044
• Device Sequence Number: 1586600
• Product Code: LIT
• UDI-Device Identifier: 00801741132803
• UDI-Public: (01)00801741132803
• 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: 436-2515L
• Device Catalogue Number: 436-2515L
• Device Lot Number: 50142830
• 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