MAUDE Adverse Event Report: COVIDIEN LP TRAILBLAZER ANGLED; CATHETER, PERCUTANEOUS

Model Number	ASC-018-150
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The ostial superficial femoral artery (sfa) was engaged using 0.46mm trailblazer angled (model# asc-018-150) and asahi astato 30 wire.Doctor upgraded to 0.035" stiff angled wire and navicross.Doctor was unable to pass the catheter beyond distal sfa and wire/catheter were changed to 0.018" v-18 and trailblazer were used as part of a second attempt.Doctor continued to have difficult time, and it was decided to perform an angioplasty of the entire sfa.The wire appeared to be in the lumen at the popliteal artery.When doctor advanced the trailblazer, it was difficult to advance and after pushing the wire, the trailblazer kinked.Doctor was unable to remove the wire and had to take the whole thing out.Hub broke off during manipulations.Wires would not slide through catheter - felt sticky.

• Brand Name: TRAILBLAZER ANGLED
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10860007
• Report Number: 10860007
• Device Sequence Number: 2470483
• Product Code: DQY
• UDI-Device Identifier: 00763000104696
• UDI-Public: (01)00763000104696
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/10/2020
• Report Date (Section F): 11/10/2020

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: Health Professional
• Device Model Number: ASC-018-150
• Device Catalogue Number: ASC-018-150
• Device Lot Number: A994258
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 85
• Date Report Sent to FDA: 11/10/2020