MAUDE Adverse Event Report: MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Physical Entrapment (2327)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed at least 15 applications were performed with a non-returned balloon catheter afapro28 with lot number 75111.Without any issue on the date of the event.A clinical issue (entrapment) occurred during the procedure.There is no indication of a malfunction of the mapping catheter related to the adverse event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure, the mapping catheter became stuck inside the right inferior pulmonary vein (ripv).The mapping catheter was extracted from the patient's body.The case was aborted.The patient's hospitalization was extended.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the mapping catheter 990063-020 with lot 218144154 was returned and analyzed.Visual inspection of the mapping catheter showed the loop section was detached from the shaft nine inches from the tip.The pebax tubing broke at two different places: at three inches and nine inches.The electrodes seven and eight were displaced.Furthermore, the pebax tubing was ribbed in the region of electrode seven.There were also bulges at four inches from the tip.The clinical issue (mapping catheter entrapment in the patient¿s body) occurred during the procedure.There is no indication of a relation of the adverse event to the performance and malfunction of the product.In conclusion, the mapping catheter failed the returned product inspection due to the detached loop, the displaced electrodes, the bulges on the pebax tubing, and the ribbing on the pebax tubing.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACHIEVE MAPPING CATHETER - 20 MM
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9569133
• MDR Text Key: 174340864
• Report Number: 9612164-2020-00168
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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,Followup
• Report Date: 02/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 218144154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2019
• 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; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 55