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

Model Number 990063-015

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Great Vessel Perforation (2152); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a cryo ablation procedure, after a freeze was delivered, and the balloon catheter was thawed and deflated, it was observed that the patient's blood pressure significantly dropped.Measures to improve the patient's blood pressure were initiated, and a pericardial effusion was observed via intracardiac ultrasound.Heparin was immediately stopped, and a heparin reversal medication was administered.A pericardiocentesis was then performed, which aspirated a significant amount of fluid.Aspiration from the pericardial drain was performed multiple times which improved the patient's blood pressure.Additionally, an anticoagulant was administered.The case was aborted, and the patient was under general anesthesia.The patient left the procedure area with still a pericardial drain in place.The patient was then scheduled for a surgical repair, and was transferred to the intensive care unit (icu) for observation.It was noted that the patient continued to be sedated and intubated post procedure.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed ten applications were performed with balloon catheter 2af284, lot number 34419 without any issues on the date of the event.Clinical issues (pericardial effusion, hypotension, perforation and aborted under general anesthesia) occurred during the case.There is no indication that the adverse event was related to the performance of the reported mapping catheter.In conclusion, there is no indication of a product malfunction of the reported mapping catheter 990063-015, lot number 216142845 in relation to the adverse event.Pending analysis of the returned product.If information is provided in the future, a supplemental report will be issued.

Event Description

Incoming information received that the mapping catheter was responsible for the perforation of the pulmonary vein.Additionally, the patient did not have to go to the operating room for surgical repair and has since been discharged from the hospital.

Manufacturer Narrative

Product event summary: the mapping catheter, 990063-015 with lot number 216142845, was returned and analyzed.Visual inspection of the mapping catheter showed the device was intact with no apparent issue.Mechanical verification of the steering functioned normal.The reported clinical issues could not be confirmed through product analysis.The mapping catheter passed the returned product inspection as per specification.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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8203063
• MDR Text Key: 131620124
• Report Number: 9612164-2018-03784
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 00643169467378
• UDI-Public: 00643169467378
• 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: 02/25/2019

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: 09/10/2020
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Device Lot Number: 216142845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/02/2019; 01/29/2019
• Supplement Dates FDA Received: 01/25/2019; 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80