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

Model Number	4FC12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)
Date of Event	11/16/2017
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 cryo ablation procedure and prior to another procedure being started, the patient became hypotensive.A tear in the atrial septum was evident via transesophageal echocardiogram.The patient is stable and is scheduled for a surgical repair.The patient's hospitalization was extended.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Event summary: multiple clinical issue (the patient became hypotensive.A tear in the atrial septum was evident via transesophageal echocardiogram) encountered during the procedure.The sheath 4fc12/93136 was not returned for investigation.In conclusion, the clinical issues (hypotensive and cardiac perforation) were encountered during the procedure.There is no indication of product malfunction.The sheath was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
(b)(6) 2017, 08:12:18: surgical intervention was performed successfully.No further patient complications have been reported as a result of this event.

• 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: 7096653
• Report Number: 3002648230-2017-00671
• Device Sequence Number: 11107341
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/04/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 93136
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR