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

Model Number 4FC12

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

This event occurred outside the u.S.Where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.Investigation is in progress.Results of investigation will be submitted in a supplemental report.(b)(4).

Event Description

It was reported that during a cryo ablation procedure, an error code had occurred indicating that the safety system detected fluid in the catheter and stopped the injection.It was noted that the catheter was de-sterilized by error.The catheter was replaced.It was further reported that the patient experienced decreased blood pressure and an echocardiography (echo) showed a pericardial effusion.The procedure was aborted and the patient was treated with drainage of the effusion.The patient was under general anesthesia and there were no patient complications reported.

Manufacturer Narrative

Product event summary: data file analysis did not demonstrate a system notice related to the adverse event.A known clinical adverse event occurred during the procedure.No product was returned for analysis.

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; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5021331
• MDR Text Key: 23714458
• Report Number: 3002648230-2015-00242
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Followup,Followup
• Report Date: 07/24/2015

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 Expiration Date: 04/27/2017
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 54687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Supplement Dates Manufacturer Received: Not provided; 09/23/2015
• Supplement Dates FDA Received: 10/21/2015; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 00061 YR
• Patient Weight: 95