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

Model Number	G11638
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During peripheral case of a lower extremity angioplasty, a cook incorporated flexor (model #: g11638) introduced raabe modification sheath broke in half and inner wire unraveled.Sheath and braiding removed successfully.Device given to cook medical sales representative at the time.Wires were withdrawn into the 55 raabe catheter, which was then pulled back over the aortic bifurcation.When we were doing this, the raabe sheath broke into 2 pieces.The proximal piece was then pulled out of the left groin and fluoroscopic images confirmed that the remainder of the raabe catheter was still stuck over the bifurcation of the aorta.Additional manipulation required to remove rest of wire and foreign bodies.

• Brand Name: FLEXOR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 6300 n. matthews dr.; ellettsville IN 47429
• MDR Report Key: 10784514
• Report Number: 10784514
• Device Sequence Number: 11644285
• Product Code: DYB
• UDI-Device Identifier: 00827002116382
• UDI-Public: (01)00827002116382
• 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): 10/20/2020
• Report Date (Section F): 10/20/2020

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: G11638
• Device Catalogue Number: KCFW-6.0-38-55-RB-RAABE
• Device Lot Number: 13329069
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 108
• Date Report Sent to FDA: 10/20/2020