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U.S. Department of Health and Human Services

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

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TELEFLEX® MEDICAL TURNPIKE® SPIRAL CATHETER CORONARY MICROCATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number 5640
Device Problems Wire (430); 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.

 
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Brand NameTURNPIKE® SPIRAL CATHETER CORONARY MICROCATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
TELEFLEX® MEDICAL
morrisville NC
MDR Report Key9971952
MDR Text Key188391472
Report NumberMW5094178
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received04/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number5640
Device LOT Number48706
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/16/2020 Patient Sequence Number: 1
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