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

Model Number G35551

Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)

Patient Problems Stenosis (2263); Foreign Body In Patient (2687)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

An elderly female with past medical history (pmh) of newly diagnosed diabetes mellitus (dm) and chronic hypertension with a two-day history of dizziness and weakness she had attributed to her new medications for dm, which made her leave work, go home, and lay down.At that point she experienced numbness and inability to move her right arm.She arrived in emergency room (er) one day (day 1) with these complaints although they had already resolved.Computerized tomography (ct) of head was negative for stroke, computed tomography angiography (cta) also negative.She was admitted for continued work-up by neurology and once again she experienced the numbness to the right face - magnetic resonance imaging (mri) showing acute left cerebellar infarct, microinfarct and chronic bilateral basal ganglia lacunar infarct.Symptoms once again completely resolved.She was taken to the cath lab and underwent a cerebral angiogram via radial artery access, two days after (day 3) the day she arrived in the er and finding were multifocal intracranial stenosis involving left mca, right mca as well as left intracranial vertebral artery.During the procedure it was noted that part of the micro-wire was stuck in soft tissue versus right radial artery near right radial puncture site and was not able to be removed.The radial access was then aborted, and groin access was obtained.Radial pulse was present and right ulnar artery was patent.Once the procedure was completed, vascular surgery was consulted, and she was taken to the or and underwent removal of foreign body and repair of right radial artery on day 4.Tolerated the procedure well, and once stable, was discharged home on day 5.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; po box 489; bloomington IN 47402 0489
• MDR Report Key: 14564213
• MDR Text Key: 293103050
• Report Number: 14564213
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2022

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
• Device Operator: Health Professional
• Device Model Number: G35551
• Device Catalogue Number: MPIS-502-10.0-SC-NT-U-SST
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2022
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: Asian