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 Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); No Code Available (3191)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed that at least 21 applications were performed with balloon catheter 2af284, with lot number 22078, without any issue on the date of the event.Clinical issues were encountered during the case.There is no indication of relation of adverse event to the performance of the cryo device.The mapping catheter was not returned for product analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following a cryo ablation procedure that was completed with cryo, the patient was unable to articulate properly.Upon visiting the hospital again, it was observed that the patient had a speech impediment and behavior disorder.Magnetic resonance imaging (mri) was performed, and it was noted that there was infarction in the occipital lobe, cerebellar and left parietal lobe.In addition, trace bleeding was noted surrounding the left parietal lobe due to reperfusion after the infarction.The patient currently has motor and speech impediment, and was in rehabilitation.A thrombus was suspected.It was noted that it was possible that the thrombus was adhered to, or remained on, the proximal side of the balloon.The patient remains hospitalized.No further patient complications have been reported as a result of this event.

• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8525147
• MDR Text Key: 142334774
• Report Number: 9612164-2019-01395
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102588
• 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: 04/17/2019

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 Expiration Date: 01/22/2021
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 216940048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2019
• 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): Hospitalization
• Patient Age: 66 YR