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

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); ST Segment Elevation (2059)

Event Date 10/17/2016

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, a competitor ring catheter was inserted into the sheath and the sheath was in the left atrium (la).The physician noted st segment elevation on the electrocardiogram (ekg) and angiography was performed and an air embolus was identified in the right coronary artery (rca).An iv medication was injected and air removal was attempted using the angiography catheter.After about twelve minutes the st elevation resolved.The transient st elevation caused temporary ischemia to the rca.The procedure was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed that multiple injections were performed with test catheters without any issue.There was no indication of a product malfunction, and no product was returned for investigation.A known clinical issue was encountered during the procedure.

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 H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6087461
• MDR Text Key: 59450680
• Report Number: 3002648230-2016-00479
• 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: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/15/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 29930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2016
• 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
• Patient Outcome(s): Life Threatening; Required Intervention