MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE; INTRODUCER, CATHETER

Model Number RSS601

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

Patient Problem Foreign Body In Patient (2687)

Event Date 12/30/2022

Event Type  malfunction  

Event Description

6f sheath was placed in femoral artery.Bleeding was noted prior to closure, and physician determined to remove sheath and replace with a 7f.Upon removal of 6f sheath, the proximal part of sheath was removed, but the distal part of sheath broke off and was left inside the patient.Patient required blood product, anesthesia, and emergent cut down and removal of the distal piece of sheath from femoral artery.Manufacturer response for (b)(4) (per site reporter).No response to date.

• Brand Name: PINNACLE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 16311327
• MDR Text Key: 308933018
• Report Number: 16311327
• 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: 01/20/2023

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: RSS601
• Device Catalogue Number: RSS601
• Device Lot Number: 266219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28470 DA
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White