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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Laceration(s) (1946); Pericardial Effusion (3271)

Event Date 09/24/2014

Event Type  Injury  

Event Description

During ablation of the left superior pulmonary vein (the 2nd ablation of the cryoablation procedure), a marked drop in blood pressure was observed in the arterial line.After reviewing intercardlac echo, it was determined that a significant amount of fluid was present in the pericardial sack.A periacrdiosentesis was performed and the patient was taken to the cvor where a tear in the roof of the left atrium was repaired.The patient is expected to make a full recovery.Additional procedure note: just after transeptal access, the patient's laryngeal mask airway (lma) was removed in favor of intubating the patient.The drop in blood pressure was noticed just after the patient was intubated.Device 2 of 3, reference mfr report: 3002648230-2014-00174 and 3007798852-2014-00016.

Manufacturer Narrative

The device is not available for investigation; it was discarded after the procedure.There was no indication of product malfunction.

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: 4194194
• MDR Text Key: 4967109
• Report Number: 3002648230-2014-00175
• Device Sequence Number: 1
• Product Code: DRA
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: No
• 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: ARCTIC FRONT ADVANCE (B)(4), ACHIEVE (B)(4)
• Patient Outcome(s): Required Intervention