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

Model Number 4FC12

Device Problems Device Contamination with Body Fluid (2317); Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817); Paralysis (1997); Speech Disorder (4415)

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, blood was drawn into the sheath via the sideport after inserting it into the patient.The balloon catheter was inserted, but blood continued to enter the sideport of the sheath.The sheath was removed and replaced, in which air ingress occurred.St elevation was then observed.A vasodilator was administered and the st elevation resolved.The case was completed with cryo.Following the procedure, the patient did not wake up from anesthesia.A magnetic resonance imaging (mri) was performed and a cerebral infarction and embolus was confirmed in the left hemisphere of the brain due to air embolism.The patient displayed signs of paralysis on their right side and had difficulty speaking.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the 4fc12 sheath with lot 0010680967 was returned and analyzed.Visual inspection prior to disassembly and functional testing was performed on the shaft, handle, and dilator.No observations were identified during the external visual inspection.Performance testing was then performed with the sentinel blackbelt leak tester.The sheath passed the test as the pressure decay in the device was within an acceptable range.Several flushes and aspirations were performed without issues while a test balloon catheter was inserted.The flush and air aspiration/ingress issue was not reproduced.There was no blockage along the shaft.The shaft and side port were leak-tight and the sheath was able to hold pressure for more than four minutes.In conclusion, the reported air ingress and visible blood were not confirmed through testing.The clinical issues of air embolism, paralysis, st elevation, and impaired speech occurred during and following the procedure.There is no indication of a relation of the adverse event to the performance and malfunction of the product.The sheath passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.

• 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: 12858701
• MDR Text Key: 285498415
• Report Number: 3002648230-2021-00541
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000217136
• UDI-Public: 00763000217136
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2023
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010680967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• 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; Required Intervention; Disability; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male