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 06/13/2017

Event Type  malfunction  

Event Description

It was reported that during a cryo ablation procedure, air ingress and transient st elevation occurred.It was noted the blood pressure did not change and was stable.St elevation was confirmed by electrocardiogram (ecg).It was noted that air was not confirmed in patient's body; however, the physician considered the st elevation was due to air.The case was completed with cryo.The patient's hospitalization was not extended.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed at least fourteen applications were performed with catheter 2af284/62488/03.Multiple applications had flow, temperature low profile or fluctuations.A clinical issue was encountered during the procedure.The flexcath advance sheath 4fc12/47537 was not returned.The reported issue does not indicate a sheath manufacturing related defect.In conclusion, this complaint is about a clinical issue encountered during the procedure.The sheath was not returned for investigation.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: 6680301
• MDR Text Key: 78793437
• Report Number: 3002648230-2017-00301
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• 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: 07/29/2017

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: 01/24/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 47537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 07/29/2017; 07/29/2017
• Supplement Dates FDA Received: 08/24/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2017
• 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