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

Model Number 4FC12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The files showed at least 12 applications were performed with a balloon catheter afapro28 with lot number 00194 on the date of the event.The file showed system notice #50014 ¿the balloon is not sufficiently inflated¿ in applications 1, 4, 5 and 8.Clinical issues (pericardial effusion, hypotension and perforation) occurred during procedure.The case was aborted under general anesthesia.In conclusion, the sheath was not returned for investigation.There is no indication of relation of adverse event to the performance and malfunction of the product.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that the balloon inflation pressure was not reached in time.The procedure was continued.It was noted that the right superior pulmonary vein (rspv) was difficult to access due to patient anatomy.The balloon catheter and mapping catheter were removed, and another catheter was used to position the sheath near the rspv ostium.The catheter was removed and the balloon catheter was reinserted.Upon the first inflation at the rspv it was noted that the patient's blood pressure was dropping and an effusion was noted on fluoroscopy.The balloon catheter and sheath were removed from the atrium and a pericardiocentesis was performed.The case was aborted with the patient under general anesthesia.Due to the amount of drainage, the patient was sent for surgery and a small perforation near the rspv was noted.The perforation was repaired and the patient's hospitalization was extended.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; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9702400
• MDR Text Key: 185943240
• Report Number: 3002648230-2020-00086
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2020

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
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 130