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 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files for the date of the reported event were returned and analyzed.The data files confirmed that three different balloon catheters had been used during the procedure.It was noted that the data files also showed a system notice unrelated to the reported issue.The sheath, 4fc12 with lot 81710, was not returned for investigation.A clinical issue (st elevation) was encountered during the procedure and resolved immediately.In conclusion, the reported air ingress was unable to be confirmed as the product was not returned; the root cause remains inconclusive.A clinical issue (st elevation) was encountered during the procedure.

Event Description

It was reported that during a cryoablation procedure, the sheath exhibited air ingress during aspiration.The balloon catheter was replaced twice without resolve.It was noted that further insertion of the sheath and slower aspiration resolved the issue.It was also reported that the patient experienced st elevation prior to the insertion of the sheath.St elevation recovered and the case was completed with cryo.No further patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5805237
• MDR Text Key: 49906527
• Report Number: 3002648230-2016-00276
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 81710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Date Device Manufactured: 01/12/2016
• 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): Other