MAUDE Adverse Event Report: COOK, INC. COOK MEDICAL 4 FR MICROPUNCTURE; INTRODUCER, CATHETER

Model Number MPIS-401-SST

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 05/15/2020

Event Type  malfunction  

Event Description

Groin site - dilator did break off in leg and required slightly larger incision, but was able to be retrieved.Will report as psi.Disclosed to patient and husband.No harm to patient.Slightly larger incision.Should not impede recovery.Hx of sah due to r pcom aneurysm s/p coil embo ((b)(6) 2014) and cva due to cerebral venous thrombosis c/b seizure presenting today for treatment of her aneurysm recurrence.Fda safety report id# (b)(4).

• Brand Name: COOK MEDICAL 4 FR MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 10082412
• MDR Text Key: 192021986
• Report Number: MW5094641
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPIS-401-SST
• Device Lot Number: 13033417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 31