MAUDE Adverse Event Report: TERUMO MEDICAL CORP. TERUMO; 6F 119CM TERUMO R2PDESTINATION SLENDER SHEATH

Model Number GS-R6ST1C112W

Device Problem Material Fragmentation (1261)

Patient Problems Occlusion (1984); Device Embedded In Tissue or Plaque (3165)

Event Date 05/29/2019

Event Type  Injury  

Event Description

Pt with acute on chronic non-healing bilateral foot ulcers, peripheral artery disease with prior stent placement right lower extremity.On (b)(6) 2019 she underwent an abdominal angiogram with runoff to the feet, with plans to intervene on occluded superior femoral artery.When the physician attempted to full the sheath back in order to redirect the wire, but in doing so the sheath came apart at the wrist (left radial access under ultrasound guidance) and began to unravel at which time further attempts at manual removal were halted.Attempts at retrieving by snaring the pieces was briefly attempted and unsuccessful, with a piece of the sheath occluding the left brachial artery.Consult was requested with vascular surgeon.Ultimately, the pt required surgical intervention, including extraction of brachial artery foreign body, direct repair of radial artery at the wrist, and fasciotomy of the left forearm.

• Brand Name: TERUMO
• Type of Device: 6F 119CM TERUMO R2PDESTINATION SLENDER SHEATH
• Manufacturer (Section D): TERUMO MEDICAL CORP. ; 265 davidson ave; somerset NJ 08873
• MDR Report Key: 8688762
• MDR Text Key: 147874080
• Report Number: 8688762
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: GS-R6ST1C112W
• Device Lot Number: XA03
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2019
• Distributor Facility Aware Date: 05/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR