MAUDE Adverse Event Report: TERUMO MEDICAL CORP. R2P DESTINATION SLENDER 119CM TERUMO SHEATH; INTRODUCER, CATHETER

Catalog Number GS-R6ST1C1ZW

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/18/2021

Event Type  Injury  

Event Description

Sheath could not be removed from left radial artery.Physician tried to give sedation to relax the artery and it did not work.He then tried to insert the dilator and it would only go in part way.He then called for anesthesia to assist with relaxing the patient.Cardiologist attempted to remove the sheath with force.Vascular surgeon was contacted.Vascular surgeon arrived and tugged on the sheath and it eventually broke in half leaving about 3 cm of sheath hanging out of the wrist.Surgeon clamped the sheath and called for operating room team to begin a cutdown to remove the remaining sheath still in the left arm.Fda safety report id# (b)(4).

• Brand Name: R2P DESTINATION SLENDER 119CM TERUMO SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP.
• MDR Report Key: 12377287
• MDR Text Key: 268732513
• Report Number: MW5103535
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2021

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 Catalogue Number: GS-R6ST1C1ZW
• Device Lot Number: XK14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2021
• 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 Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 98