FDA Adverse Event Malfunction Summary report: N

FLEXCATH ADVANCE STEERABLE SHEATH

MDR report key: 5526430 · Received March 25, 2016

Report

Report Number: 3002648230-2016-00108
Event Type: Malfunction
Date Received: March 25, 2016
Report Date: May 30, 2016
Manufacturer: MEDTRONIC CRYOCATH LP
Product Code: DRA
PMA / PMN Number: K123591
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVENT SUMMARY: PATIENT DATA FILES WERE NOT RECEIVED FOR THIS CASE. UPON VISUAL INSPECTION OF FLEXCATH SHEATHS 4FC12 / 81715-33, 81715-66, AND 81715-68 SHOWED THE DEVICES WERE INTACT WITH NO APPARENT ISSUES. AIR ASPIRATION WAS REPRODUCED WHEN A TEST ARCTIC FRONT CATHETER WAS INTRODUCED THROUGH THE SHEATHS. DISSECTION SHOWED THE HEMOSTATIC VALVES WERE LEAKING; VALVES WERE TORN. IN CONCLUSION, THE REPORTED ISSUE HAS BEEN CONFIRMED THROUGH TESTING. THE FLEXCATH SHEATHS FAILED THE RETURNED PRODUCT INSPECTION DUE TO LEAKING HEMOSTATIC VALVE.

Additional Manufacturer Narrative · 1

THE MANUFACTURER POSTAL CODE (B)(4). THE CODE WAS REMOVED TO FACILITATE TIMELY REGULATORY REPORT SUBMISSION, AND SOLELY AS A TEMPORARY WORKAROUND TO A VALIDATION ISSUE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING PRE-OP OF A CRYOABLATION PROCEDURE, THERE WAS A VALVE LEAK REGARDING THE SHEATH. THE SHEATH WAS REPLACED. THIS WAS NOT CASE RELATED, AND THERE WAS NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
181873	FLEXCATH ADVANCE STEERABLE SHEATH	CATHETER, STEERABLE	DRA	MEDTRONIC CRYOCATH LP	4FC12	81715

Patients

Seq	Age	Sex	Outcome	Treatment
1