MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 7840

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problems Fistula (1862); Perforation of Vessels (2135); Pseudoaneurysm (2605)

Event Date 07/26/2021

Event Type  Injury  

Event Description

It was reported via medwatch mw5103876 that catheter entrapment and detachment occurred.The patient presented for an outpatient cardiac catheterization procedure.A non-boston scientific sheath and a 5f expo guide catheter were inserted with no issues or concerns.When the physician 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 vessels were tortuous which contributed to the complication.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 arteriovenous (av) fistula consistent with a perforated vessel.

• Brand Name: EXPO GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12586588
• MDR Text Key: 275141364
• Report Number: 2134265-2021-12546
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729007692
• UDI-Public: 08714729007692
• Combination Product (y/n): N
• PMA/PMN Number: K120495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2023
• Device Model Number: 7840
• Device Catalogue Number: 7840
• Device Lot Number: 0060290408
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention