FDA Adverse Event Malfunction Summary report: N

FLEXCATH SELECT STEERABLE SHEATH

MDR report key: 8933550 · Received August 26, 2019

Report

Report Number: 3002648230-2019-00622
Event Type: Malfunction
Date Received: August 26, 2019
Date of Event: June 25, 2019
Report Date: August 26, 2019
Manufacturer: MEDTRONIC CRYOCATH LP
Product Code: DYB
UDI-DI: 00643169688858
PMA / PMN Number: K142684
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE SHEATH, 990065 WITH LOT NUMBER 51301, WAS RETURNED AND ANALYZED. VISUAL INSPECTION OF THE SHEATH SHOWED THAT THE SHAFT AS KINKED (PINCHED) AT 2.328 INCHES PROXIMAL FROM THE TIP. FUNCTIONAL TESTING SHOWED THE DEFLECTION MECHANISM WAS WORKING WITH DIFFICULTY DUE TO THE KINKS ON THE SHAFT; THE PULL WIRE WAS NOT BROKEN. IN CONCLUSION, THE SHEATH FAILED THE RETURNED PRODUCT INSPECTION DUE TO THE SHAFT KINK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A RADIOFREQUENCY (RF) PROCEDURE, THE SHEATH WAS HAVING DIFFICULTY MANEUVERING. IT WAS THEN OBSERVED THE SHEATH WAS KINKED AND WAS REPLACED. THE SECOND SHEATH ALSO HAD MANEUVERABILITY ISSUES AND WAS ABLE TO BE MANIPULATED WITH RESOLVE IN ORDER TO PERFORM RF. THE CASE WAS COMPLETED WITH RADIOFREQUENCY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE SECOND SHEATH SUBSEQUENTLY TESTED OUT OF SPECIFICATION PER THE MANUFACTURER'S INVESTIGATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
727095	FLEXCATH SELECT STEERABLE SHEATH	INTRODUCER, CATHETER	DYB	MEDTRONIC CRYOCATH LP	990065	51301	00643169688858

Patients

Seq	Age	Sex	Outcome	Treatment
1