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

Model Number 4FC12

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2017

Event Type  malfunction  

Event Description

It was reported that during a cryo ablation procedure, the sheath kinked while being inserted.The sheath was replaced with resolve, and the case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Visual inspection of the sheath showed that the shaft was not intact.The sideport tube was detached and the dilator shaft was kinked at the distal tip.No fracture, breakage or delamination were observed on sheath or dilator.In conclusion, the sheath kink issue was not confirmed through testing; however, the dilator was kinked at the end.The sheath failed the returned product inspection due to a dilator kink and the sideport tube was detached.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: the dilator kink most likely occurred after the procedure during transportation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Visual inspection of the sheath showed that the shaft was not intact.The sideport tube was detached and the dilator shaft was kinked at the distal tip.No fracture, breakage or delamination were observed on sheath or dilator.In conclusion, the sheath kink issue was not confirmed through testing; however, the dilator was kinked at the end.The sheath failed the returned product inspection due to a dilator kink and the sideport tube was detached.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7009564
• MDR Text Key: 92489553
• Report Number: 3002648230-2017-00599
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 43603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 11/28/2017; 12/20/2017; 02/27/2018; 03/19/2018
• Supplement Dates FDA Received: 12/19/2017; 12/21/2017; 03/06/2018; 03/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2017
• 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: 57 YR