FDA Adverse Event Malfunction Summary report: N

OVER-THE-WIRE EMBOLECTOMY CATHETER

MDR report key: 2912850 · Received December 3, 2012

Report

Report Number: 1220948-2012-00020
Event Type: Malfunction
Date Received: December 3, 2012
Date of Event: October 22, 2012
Report Date: November 5, 2012
Manufacturer: LEMAITRE VASCULAR, INC.
Product Code: DXE
PMA / PMN Number: K022145
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND WERE ABLE TO CONFIRM THE FAILURE: THE TIP OF THE CATHETER WAS DETACHED. ADDITIONALLY, THE LUMEN OF THE CATHETER WAS STRETCHED/ELONGATED. THE MOST PROBABLE ROOT CAUSE OF THE FAILURE IS FROM EXCESSIVE FORCE USED DURING THE PROCEDURE. THE LEMAITRE VASCULAR IFU WARNS TO EXERCISE CAUTION WHEN ENCOUNTERING EXTREMELY DISEASED VESSELS AND AVOID USING EXCESSIVE FORCE TO PUSH OR PULL CATHETER AGAINST RESISTANCE. THE PHYSICIAN DID NOT TAKE INTO CONSIDERATION THESE WARNINGS WHILE HE PERFORMED THE PROCEDURE. A LOT HISTORY INVESTIGATION WAS PERFORMED. THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING THE MANUFACTURING AND PACKAGING PROCESSES AND THERE WERE NO UNRESOLVED ISSUES RELATED TO THE COMPLAINT EVENT. IN ADDITION, PLEASE NOTE THAT THE PT IS OKAY.

Description of Event or Problem · 1

THE PHYSICIAN PERFORMED THROMBECTOMY. DURING THE PROCEDURE, THE TIP OF THE CATHETER (THE BALLOON AREA) WAS DETACHED WHEN THE SURGEON PULLED THE CATHETER OUT OF THE PT LEG. THE TIP OF THE CATHETER WAS SUBSEQUENTLY REMOVED FROM THE PT. THE PT IS RECOVERED WITHOUT FURTHER INCIDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OVER-THE-WIRE EMBOLECTOMY CATHETER	DUAL LUMEN EMBOLECTOMY CATHETER	DXE	LEMAITRE VASCULAR, INC.	10 MM (4F) - 80 CM	OTW2289

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other