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

Model Number 3FC12

Device Problems Material Too Rigid or Stiff (1544); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Product event summary: the device, flexcath steerable sheath (3fc12 / 18545-07), was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issues.It was noted that the sheath failed to deflect due to pull wire detachment from the ring.Dissection showed a shaft breach was found inside the handle at the distal end of the guide rod.Signs of adhesive were also found on the shaft inside the handle.In conclusion, the reported issue (shaft breach inside the flexcath handle) was confirmed through testing.The sheath failed the inspection due to pull wire detachment from the ring and shaft breach inside the handle.(b)(4).

Event Description

It was reported that during a cryoablation procedure, the sheath had flexibility issues with bending.The sheath was replaced with a new one and the procedure was able to be completed with cryo.The device subsequently tested out of specification during the manufacturer's analysis.No patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH 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: 5144978
• MDR Text Key: 28501392
• Report Number: 3002648230-2015-00356
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Model Number: 3FC12
• Device Catalogue Number: 3FC12
• Device Lot Number: 18545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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 Age: 00060 YR