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

Model Number 990063-020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Vasoconstriction (2126)

Event Date 03/24/2016

Event Type  Injury  

Event Description

It was reported that during a cryoablation procedure, during the first ablation of the left inferior pulmonary vein (lipv), the patient experienced abrupt st elevation followed by rapid onset of ventricular tachycardia (vt).Persistent vt and lack of adequate blood pressure caused the need for cardiopulmonary resuscitation (cpr).Prior to the compressions beginning, the balloon catheter was removed from the body and the sheath was moved into the right atrium.Cpr continued until the vt ceased and adequate blood pressure returned.A coronary angiogram was performed; the physician stated that the right coronary artery was showing mild vasospasm, which was then relieved by nitroglycerin.It was noted that no acute coronary lesions were observed.The balloon catheter was replaced and the procedure continued.The case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files , balloon catheter and mapping catheter were returned.Data files showed a system notice unrelated to the clinical issue occurred.The catheters passed the performance and electrical tests.Dissection and pressure test didn¿t show any leaks or traces of blood or liquid.A clinical issue was encountered during the procedure.

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 MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5550348
• MDR Text Key: 41980143
• Report Number: 9612164-2016-00312
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2016

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: 04/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/06/2016
• Supplement Dates Manufacturer Received: Not provided; 05/31/2016
• Supplement Dates FDA Received: 06/24/2016; 09/21/2017
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 00062 YR
• Patient Weight: 62