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 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a cryoablation procedure, st elevation was observed.The physician noted that this issue was due to air ingress.The st elevation recovered without intervention.The case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed at least eight applications were performed with catheter 2af284 / 05457-58 without any issue on the date of the event.This is a clinical adverse event during the procedure: st segment elevation due to air ingress was observed.The flexcath sheath 4fc12/30514 was not returned.In conclusion, this complaint is about a clinical issue (st segment elevation due to air ingress) during the procedure.The sheath was not returned for analysis.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: 7068234
• MDR Text Key: 93724131
• Report Number: 3002648230-2017-00649
• 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
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 30514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2017
• 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