MAUDE Adverse Event Report: COVIDIEN LP WHOLEY; CATHETER, PERCUTANEOUS

Model Number WWFS35145

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

A patient with end-stage renal disease was admitted to the cardiac catherization lab for elective cardiac catherization.Towards the end of the procedure, there was difficulty removing the covidien lp wholey guidewire system.The guidewire was stuck in the patient due to aggressive vasospasm despite the administration of additional sedation and vasodilators.Medical doctor was able to withdraw the catheter and wire down the arm and the catheter out of the body but the wire tip was stuck in the forearm just distal to the sheath tip.Md felt the safest way to remove the wire and sheath together in unison but when he pulled the wire and sheath back as a unit, the wire tip sheared and a wire fragment was dislodged.Vascular surgery was consulted and patient underwent resection of right radial artery and removal of retained wire.

• Brand Name: WHOLEY
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10401050
• MDR Text Key: 202734114
• Report Number: 10401050
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/03/2020

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
• Device Operator: Health Professional
• Device Model Number: WWFS35145
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 62