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

Model Number 4FC12

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pericardial Effusion (3271)

Event Date 11/01/2015

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.

Event Description

It was reported that three days post cryo ablation procedure drainage of a pericardial effusion was conducted.The date that the effusion occurred is unknown as the information came from a third party distributor.It was additionally reported that during the cryo ablation procedure that when accessing the left atrium with the sheath the guide wire "came out" of the left atrium and therefore, the left atrium was accessed with the balloon catheter.The procedure was completed with cryo and the effusion was later discovered.No further patient complications have been reported as a result of this event.

• 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: 5242923
• MDR Text Key: 31842863
• Report Number: 3002648230-2015-00409
• 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
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2015
• 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
• Treatment: 2AF284 BALLOON CATHETER,990063-020 MAPPING CATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention