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

Model Number 4FC12

Device Problems Break (1069); Kinked (1339); Physical Resistance (2578); Detachment of Device or Device Component (2907)

Patient Problem ST Segment Elevation (2059)

Event Date 06/19/2015

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure the physician attempted to place the balloon catheter through the sheath and felt quite a bit of resistance and the catheter kinked.A second balloon catheter was used and after two ablations the physician observed air bubbles and the patient's electrocardiogram (ekg) demonstrated st segment elevation.The balloon catheter was removed and the patient was given medications to be stabilized.The procedure was resumed using the second balloon catheter, which when reinserted through the sheath, kinked again.The entire system (the balloon catheter and sheath) was replaced.When the physician was positioning the mapping catheter on the right side of the heart, there was resistance felt; the mapping catheter was removed and it was noted that the tip of the catheter was missing and the thread wires were visible.The physician was unable to clear the obstructed distal tip within the balloon catheter and a new balloon catheter (the fourth one for this procedure) and mapping catheter were then replaced.The procedure was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.The device has not yet been analyzed.Results of evaluation of returned device will be submitted in a supplemental report.(b)(4).

Manufacturer Narrative

Product event summary: the flexcath advance 4fc12 / 78043-97 and data files were returned and analyzed.The data files did not show any notices for the event date.Visual inspection of the sheath showed the device was intact with no apparent issues.Air aspiration was not reproduced even with/ without catheter/dilator inside the sheath.Dissection showed the hemostatic valve was not leaking, but a shaft breach was found inside the handle at distal end of guide rod.Signs of adhesive were also found on the shaft inside the handle.The reported air ingress issue has been confirmed through testing as flexcath advance 4fc12 / 78043-97 failed the returned product inspection due to a shaft breach inside the handle.St elevation is a known clinical issue encountered during the procedure.(b)(4).

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: 4921870
• MDR Text Key: 6434342
• Report Number: 3002648230-2015-00186
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2017
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 78043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2015
• 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