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

Model Number 4FC12

Device Problem Leak/Splash (1354)

Patient Problem Paresis (1998)

Event Date 12/10/2014

Event Type  Injury  

Manufacturer Narrative

The returned device was visually inspected and functionally tested.Visual inspection showed the device was intact with no apparent issues.Air aspiration bubbles were reproduced (seen in the sideport).Dissection showed that the hemostatic valve was leaking; valve was torn.The stopcock was attached and no leaks were found along the sideport tube.

Event Description

Information received by medtronic indicated that the aspiration port (side port) of the sheath was leaking and that it was not possible to aspirate the sheath.The sheath was replaced with another one with the same lot number and the same problem was observed.The sheath was replaced with another sheath with a different lot number.The patient experienced left side hemiparalysis and was hospitaized.Patient recovered partially; recovered ability of hand and leg movement but still showed neurological deficit.Device 2 of 2, reference mfr report: 3002648230-2015-00002.

Manufacturer Narrative

The device has not yet been returned for evaluation.Results of evaluation of returned device will be submitted in a supplemental report.

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,qc H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: voula radiotis ; 16771 chemin ste-marie; kirkland,qc H9H 5-H3 ; CA H9H 5H3 ; 5146941212
• MDR Report Key: 4381638
• MDR Text Key: 13017045
• Report Number: 3002648230-2015-00003
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2016
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 08365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2014
• 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
• Patient Age: 00065 YR