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

Model Number	4FC12
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that post-operatively to a cryo ablation procedure, transient ischemic attack occurred.It was noted that air may have flushed into a sheath.The patient fully recovered the following day to the procedure.No further patient complications have been reported as a result of this event.(b)(6) 2017, 10:11:54: incoming information indicated that the hospital staff flushed air into the sheath while attempting to draw blood.
Additional Manufacturer Narrative
Event summary: the patient data files showed at least twelve applications were performed with catheter 2af284 / 35598-48 without any issue on the date of the event.This case is a clinical issue encountered post procedure (transient ischemic attack) the reported flexcath advance 4fc12/43612 involved during the case was not returned.In conclusion, this is a case related to a clinical issue (transient ischemic attack).Unable to investigate the air ingress issue as the sheath involved during the case was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 7050090
• Report Number: 3002648230-2017-00636
• Device Sequence Number: 16536959
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 43612
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR