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

Model Number 4FC12

Device Problems Air Leak (1008); No Apparent Adverse Event (3189)

Patient Problems Stroke/CVA (1770); ST Segment Elevation (2059)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure, while a mapping catheter of a competitor's product was used to check potentials, st level increased.Nitroglycerin was administered and coronary imaging was performed but it could not identify there was air.In the physician's opinion, there was possibility to occur air ingress.The procedure was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: event summary: the sheath was not returned.Data files were received and analyzed.Data files cannot confirm st levels increasing or possible air ingress on the date of the event.A catheter was used for 10 applications without any issues on the date of the event.

Event Description

The physician could not confirm air ingress under fluoroscopy on the date of the procedure ((b)(4)), and according to the representative, "physician did not complaint (sic) leaking or air aspiration issue on the mdt device." subsequently, on (b)(6) when the representative met with the physician, the physician reported that the patient exhibited stroke-like symptoms, and at that time opined that air ingress was suspected to have caused the stroke.

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: 6131906
• MDR Text Key: 61022056
• Report Number: 3002648230-2016-00502
• 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: 10/19/2016

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: 07/20/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 29994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided; 11/28/2016
• Supplement Dates FDA Received: 12/26/2016; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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