MAUDE Adverse Event Report: TERUMO MEDICAL CANADA, INC. BOSTON SCIENTIFIC DIAGNOSTIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 08526-89

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Pain (1994); Perforation of Vessels (2135); Pseudoaneurysm (2605); Swelling/ Edema (4577)

Event Date 07/26/2021

Event Type  Injury  

Event Description

During an outpatient cardiac cath procedure there was a supply malfunction that lead to patient harm.The sheath and catheter were inserted with no issues or concerns.When the md tried to remove the catheter, it became stuck in the sheath, and came apart.The pieces were successfully removed, and in the process a vessel was perforated.The patient's vessels were tortuous, which contributed to the complication he experienced.Manual pressure was applied, and bleeding stopped.The patient experienced forearm pain and swelling.The patient was admitted and provided pain control, a repeat ultrasound and cardiology care.The patient experienced a radial artery pseudoaneurysm and av fistula, consistent with a perforated vessel, and a known complication of the procedure.The catheter and sheath were sequestered and provided to the two vendors for an investigation.We are reporting the supplies to fda medwatch.Our hospital system has been successfully using the supplies for over 3 years for one product and 6 for the other.The products performance over time meets supply chain standards.Interviews were conducted with the team and cardiologist.None of team could find any opportunity areas.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC DIAGNOSTIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO MEDICAL CANADA, INC.; vaughn, ontario L6A 5 A6; CA L6A 5A6
• MDR Report Key: 12466807
• MDR Text Key: 272448158
• Report Number: MW5103876
• Device Sequence Number: 2
• Product Code: DQO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Catalogue Number: 08526-89
• Device Lot Number: 60290408
• 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; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 97