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 Tamponade (2226); 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, a drop in blood pressure was noted after isolating the left inferior pulmonary vein.The heart was xrayed which showed little to no cardiac motion.A scan was done which revealed a moderate sized effusion had developed on the anterior aspect of the right ventricle.A pericardial tap was performed immediately, which resulted in improvement of hemodynamics.The patient was extubated without issue and admitted to the hospital.The patient was doing fine several hours post procedure according to the physician.The case was aborted while the patient was under general anesthesia.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Data files showed that 10 applications were performed with a catheter without any issue on the date of the event.Visual inspection of the sheath showed that the device was intact with no apparent issues.A dissection revealed that the pull wire was bent causing resistance at the barrel, which restricted the sheaths manipulation.In conclusion, this event was related to clinical issues (cardiac tamponade, hypotension, pericardial effusion blood pressure drop and patient was under general anesthesia) encountered during the procedure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Visual inspection of the sheath showed that the device was intact with no apparent issues.The shaft had deflected as per specification.A friction noise was identified at the barrel when steering the sheath.A dissection revealed that a pull wire was bent causing resistance at the barrel.Which restricted the sheath manipulation resulting in friction noise.In conclusion, this event was related to clinical issues (cardiac tamponade, hypotension, pericardial effusion blood pressure drop and patient was under general anesthesia) encountered during the procedure.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: 7596658
• Report Number: 3002648230-2018-00376
• Device Sequence Number: 10807290
• 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): 10/02/2018

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
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/14/2018; 07/10/2018; 08/08/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/03/2018; 07/10/2018; 10/02/2018
• 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; Life Threatening; Required Intervention