MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE; INTRODUCER, CATHETER

Model Number	G47940
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient admitted for pain in left leg and some in the right leg while walking, consistent with peripheral claudication.During an attempted intervention of an occluded stent, the tip of a wire broke off in the patient and was entrapped between the stent and the arterial wall.Excerpts from procedural record: ultrasound, fluoroscopic guidance used to obtain access to the popliteal artery using a micropuncture with microsheath placement via modified seldinger technique.There was difficulty advancing the microwire and part of the microwire was fractured with a piece inside the distal sfa stent.Complication: micropuncture wire piece remains in vessel (left distal superficial femoral artery).

• Brand Name: MICROPUNCTURE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7320415
• Report Number: 7320415
• Device Sequence Number: 18859383
• Product Code: DYB
• UDI-Device Identifier: 00827002479401
• UDI-Public: (01)00827002479401(17)201121(10)8393553
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2018
• Report Date (Section F): 03/02/2018

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: Physician
• Device Expiration Date: 11/21/2020
• Device Model Number: G47940
• Device Catalogue Number: MPIS-401-SST
• Device Lot Number: 8393553
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO OTHER THERAPIES
• Patient Age: 63 YR
• Patient Weight: 59
• Date Report Sent to FDA: 03/02/2018