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

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problem ST Segment Elevation (2059)

Event Date 03/09/2017

Event Type  malfunction  

Event Description

It was reported that during a cryo ablation procedure, st elevation was observed with the first ablation of the left superior pulmonary vein (lspv).It was then confirmed that st elevation returned back to normal without intervention.The physician attributed the st elevation to air entered from the balloon catheter and the sheath.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed on the date of the event that twelve applications were performed without issue.The flexcath advance sheath (4fc12/52009) was not returned for investigation.This complaint is about several clinical issues encountered (st elevation, air ingress) during the procedure.No product malfunction reported.The reported issue does not indicate manufacturing related defect.In conclusion, this event is about several clinical issues encountered (st elevation, air ingress) during the procedure.The sheath was not returned for investigation.

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: 6455684
• MDR Text Key: 71577958
• Report Number: 3002648230-2017-00150
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 52009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• 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