MAUDE Adverse Event Report: MEDTRONIC ABLATION FRONTIERS ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Insufficient Information (3190)

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

Event Date 10/01/2014

Event Type  Injury  

Event Description

Initial transseptal access was performed without difficulty.Cryoablation catheter, sheath and mapping catheter were introduced together into the la.No resistance was encountered at the groin site or the interatrial septum.The physician explored the left sided pulmonary veins with the mapping catheter.As the signals were activated on the recording system, they were noted to be large and aligned with ventricular signals in the cs.Since the mapping catheter location was unclear, the physician withdrew the catheter and replaced in the lipv.The cryoballoon was inflated.Contrast was injected in preparation for ablation.At this time, the patient's blood pressure dropped abruptly.Ice review of the pericardium showed a large pericardial effusion.Heparin was reversed with protamine.Pericardiocentesis was emergently performed.Blood removed from the pericardium was autotransfused back to the patient.Despite normalization of the act, the pericardial effusion persisted for nearly an hour.The patient was then transferred for surgical repair.Patient did well in surgery and had a small tear in the left atrial appendage repaired.Device 3 of 3, reference mfr report: 3002648230-2014-00183 and 3002648230-2014-00184.

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

The returned device was visually inspected and passed inspection as per specification.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC ABLATION FRONTIERS; 2210 faraday avenue, suite 100; carlsbad CA 92008
• 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: 4210257
• MDR Text Key: 20773822
• Report Number: 3007798852-2014-00018
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102588
• 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,Followup
• Report Date: 10/01/2014

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 Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2014
• Initial Date FDA Received: 10/29/2014
• Supplement Dates Manufacturer Received: Not provided; 11/26/2014
• Supplement Dates FDA Received: 12/19/2014; 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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 2AF284,FLEXCATH ADVANCE 4FC12
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 00065 YR
• Patient Weight: 166