MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problems Improper or Incorrect Procedure or Method (2017); Extrusion (2934)

Patient Problem Perforation of Vessels (2135)

Event Date 10/06/2014

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: the device, flexcath advance sheath 4fc12 with lot number 39916-96, was returned and analyzed.Visual inspection showed the device was intact with no apparent issues.Deflection worked as per specification.No indication of a product malfunction.The device passed the returned product inspection as per specification.This was a known clinical issue encountered during the procedure and no product malfunction was reported or indicated upon analysis.(b)(4).

Event Description

It was reported that during a cryoablation procedure while exchanging the transseptal sheath to the access sheath, the superficial femoral vein was perforated by the access sheath.Additionally, it was reported that when the vessel was accessed it was punctured.The access device was removed and the vessel was punctured again.Perforation was attributed to poor vessel access by the physician.The procedure was aborted.No further patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5084277
• MDR Text Key: 26048130
• Report Number: 3002648230-2015-00298
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 39916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00052 YR