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	No Code Available (3191); Pericardial Effusion (3271)
Date of Event	05/21/2018
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 during a cryo ablation procedure, an anterior moderate pericardial effusion was noticed.The physician discontinued heparin, removed balloon and sheath into the right heart, and did immediate pericardiocentesis.Intracardiac echo showed removal of 550 ml of fluid.Protamine was given, ablation was not resumed.The adverse event resolved and the patient was discharged from the hospital with no signs of residual effusion.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information reported that the hospital stay was not extended.An echocardiogram the following day showed no effusion and the patient had a follow up echo a week later which showed no effusion.The case was aborted and the patient was under general anesthesia.
Additional Manufacturer Narrative
Correction: this event is a duplicate of fda report number 3002648230-2018-00376.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7593665
• Report Number: 3002648230-2018-00375
• Device Sequence Number: 1383211
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 02/20/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 94328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018; 07/11/2018; 08/08/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 06/12/2018; 07/11/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2AF284-BALLOON CATHETER, 2ACH20-MAPPING CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 72