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

Model Number 4FC12

Device Problems Kinked (1339); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Known Impact Or Consequence To Patient (2692); Pericardial Effusion (3271)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure, the patient experienced a pericardial effusion.The procedure was aborted while the patient was under general anesthesia after changes in the patient's blood pressure were noticed and the effusion was visualized on intracardiac ultrasound.The effusion was drained and the patient was stabilized.Following the procedure, the patient was sent to the intensive care unit (icu).No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed at least seven injections were performed with catheter 2af284 / 37304-54 on the date of the event with no system issue.Upon visual inspection of the flexcath sheath 4fc12, results showed the device kinked in the shaft.Flexcath 4fc12/58270-084 failed the test due to kink in the shaft.In conclusion, the reported issues (pericardial effusion, hypo, aborted) have been not confirmed through testing and data analysis.The sheath failed the test due to kink in the shaft.The risk of the patient being under general anesthesia without full therapeutic effect is also an adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 6680092
• MDR Text Key: 78782138
• Report Number: 3002648230-2017-00299
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• 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,Followup,Followup
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 58270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2017
• 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
• Treatment: 2AF284 CATHETER, 990063-020 CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 109