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

Model Number	7840
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Fistula (1862); Perforation of Vessels (2135); Pseudoaneurysm (2605)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12586588
• Report Number: 2134265-2021-12546
• Device Sequence Number: 3067779
• Product Code: DQO
• UDI-Device Identifier: 08714729007692
• UDI-Public: 08714729007692
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention