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

Model Number	G11636
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Female with past medical history significant for diabetes, obesity, hypertension, strong family history of heart disease, ex-smoker, who presented with sudden onset of chest pain.While performing an angiography, flexor check flo introducer raabe sheath's wire uncoiled from sheath when removing.Wire cut physicians hand and was left inside patient's right arm.Patient required additional surgery to have wire removed."we had difficulty in taking out sheath and patient was heavily sedated despite of the fact there was difficulty in taking out the sheath.We gave nitro boluses and pull the sheath up to axillary from ascending aorta and pull the sheath aggressively while the patient was adequately pain controlled.However, we noticed that sheath broke/fractured.After the breaking of the sheath there was a segment of sheath that was left in the axillary artery.Wire was also seen coming out of the vessel/ radial artery which was pulled, but there was still residual wire left in the radial artery.We called the vascular surgeon on call and patient will be taken to the operating room.

• Brand Name: FLEXOR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 6300 n. matthews dr; ellettsville IN 47429
• MDR Report Key: 9631508
• Report Number: 9631508
• Device Sequence Number: 2800213
• Product Code: DYB
• UDI-Device Identifier: 00827002116368
• UDI-Public: (01)00827002116368(17)220129(10)9482720
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/17/2020
• Report Date (Section F): 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G11636
• Device Catalogue Number: KCFW-6.0-38-70-RB-RAABE
• Device Lot Number: 9482720
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 112
• Date Report Sent to FDA: 01/17/2020