MAUDE Adverse Event Report: TELEFLEX/VASCULAR SOLUTIONS LLC. TURNPIKE GOLD CATHETER; CATHETER, PERCUTANEOUS

Model Number TURPIKE GOLD

Patient Problem Insufficient Information (4580)

Event Date 11/07/2023

Event Type  Injury  

Event Description

Interventional coronary catheter became stuck in a coronary artery.Requiring lengthy and exhaustive effort to remove the device resulting in limited flow during the time of entrapment.Blood flow was restored upon removal with residual disection that did not require further intervention.

• Brand Name: TURNPIKE GOLD CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX/VASCULAR SOLUTIONS LLC.
• MDR Report Key: 18122565
• MDR Text Key: 328128030
• Report Number: MW5148052
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• 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: 11/08/2023

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: TURPIKE GOLD
• Device Catalogue Number: 5621
• Device Lot Number: 714806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian