MAUDE Adverse Event Report: TELEFLEX® MEDICAL TURNPIKE® SPIRAL CATHETER CORONARY MICROCATHETER; CATHETER, PERCUTANEOUS

Model Number 5640

Device Problems Fracture (1260); Material Perforation (2205)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/02/2020

Event Type  Injury  

Event Description

The patient underwent successful orbital atherectomy and percutaneous coronary intervention of the rca (right coronary artery), extending from ostial rca to the mid pda (posterior descending artery) with overlapping xience des.The procedure was complicated by fracture of a turnpike spiral microcatheter nose cone into the heavily calcified mid pda lesion.This was successfully treated by exclusion of the retained foreign body from the lumen of the vessel using antegrade dissection and re-entry technique.The fractured portion of the microcatheter was not removed because of the concern that snaring and pulling at the device would lead to avulsion of the vessel with the potential of death.The procedure was also complicated by wire perforation at the mid pda site.This was successfully treated with prolonged balloon tamponade and protamine infusion.The outcome was confirmed in the cath lab with definity contrast assisted tte demonstrating no extravasation of contrast of pericardium.

• Brand Name: TURNPIKE® SPIRAL CATHETER CORONARY MICROCATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX® MEDICAL; morrisville NC
• MDR Report Key: 9971952
• MDR Text Key: 188391472
• Report Number: MW5094178
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5640
• Device Lot Number: 48706
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 80 YR
• Patient Weight: 75