MAUDE Adverse Event Report: COOK INCORPORATED COOK 5 FR. MICROPUNCTURE SET; INTRODUCER, CATHETER

Catalog Number G48006

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/28/2023

Event Type  Injury  

Event Description

Surgeon was using a cook 5fr micropuncture in the right femoral groin, according to the doctor she inserted the micropuncture hypo, then wire, removed the hypo and inserted the micropuncture sheath, as she then attempted to remove the wire it broke leaving a portion of the wire in the artery.Interventional radiologist was called to assist to snare the wire out.Radiologist successfully removed the broken wire intact.The removal/snare of the wire was done with fluoroscopy and snares.

• Brand Name: COOK 5 FR. MICROPUNCTURE SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED
• MDR Report Key: 17288390
• MDR Text Key: 318752878
• Report Number: MW5119228
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G48006
• Device Lot Number: 15255032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White