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

Model Number 4FC12

Device Problem Gas/Air Leak (2946)

Patient Problems Stroke/CVA (1770); Paralysis (1997); ST Segment Elevation (2059)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, st elevation was observed by a left atrium angiography when the transseptal puncture was performed.It was then reported that air ingress occurred because air aspiration was not performed sufficiently after the dilator was removed.The case was completed with cryo.When the patient awoke, paralysis of the lower left extremities was noted.A magnetic resonance imaging (mri) and computerized tomography (ct) showed an acute stage cerebral infarction.The patient was transferred to the intensive care unit (icu) and an anti-platelet agent and medication for stroke recovery were administered.The patient underwent rehabilitation and recovered after three weeks of hospitalization.No further patient complications have been reported asa result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed at least six applications were performed with balloon catheter, 2af284 with lot number 17148 on the date of the event without any issue.Clinical issues were encountered during the procedure.The sheath was not returned for investigation.There is no indication of relation of adverse event to the performance of the sheath.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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7985636
• MDR Text Key: 124390063
• Report Number: 3002648230-2018-00742
• Device Sequence Number: 1
• Product Code: DRA
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 45103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2018
• 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