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

Model Number 990063-020

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2015

Event Type  malfunction  

Manufacturer Narrative

Product event summary: preliminary investigation: preliminary analysis of data files showed the system notice #50003 ¿the pressure is low in the system¿ at injection 2 (most likely due to a low refrigerant tank) which is unrelated to the reported issue.The provided pictures confirmed a loop array detachment (broken nitinol wire).Investigation is in progress; these are preliminary results.Final results of the investigation will be submitted in a supplemental report.(b)(4).

Event Description

It was reported that during a cryo ablation procedure there was difficulty removing the mapping catheter from the right inferior pulmonary vein (ripv).The difficulty was encountered after the cryo therapy was done and the physician was attempting to retract the catheter wire from the ripv.The catheter was able to be manipulated with clock-wise movement and it was positioned more distally within the ripv and at this point it was again attempted to pull back on the catheter for removal.The loop at the distal tip of the catheter then broke off inside the ripv.The loop of the tip of the catheter remained imbedded in the vein and this was confirmed with fluoroscopy.The physician commented that catheter felt like it "lost tactile feel and the torque transfer was a little delayed".Upon removal of the remaining catheter from the patient the physician noted that the end of the catheter appeared twisted.The imbedded portion remained fixated to the vein and the patient remained stable with no change to vital signs, neurological status orcardiopulmonary status.The patient was maintained on anticoagulants and was given options regarding the imbedded catheter portion.The decision to monitor the vein, remain on anticoagulation therapy for six months and not intervene to remove the catheter portion was made by the patient and family.The patient was observed in the hospital overnight and a chest x-ray done the day following the procedure demonstrated that the fragment was stable and still in the vein.The patient then discharged from the hospital.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device, mapping catheter 990063-020 with lot number 209214035, and data files were returned and analyzed.Data files did not show any system notices relating to the device.Visual inspection showed a missing array section of the device with a twisted flex shaft (pebax) where a fracture occurred.The flex shaft material appeared stretched and elongated.The length of the returned device was compared to a reference achieve mapping catheter.There was approximately five centimeters of the catheter in total that was absent.Based on the evidence from the returned device, the nitinol wire broke off just above the ninety degree section and all eight electrodes were included on the missing loop section (as per reported event description, the missing loop of the tip of the catheter remained imbedded in the patient¿s vein).No dissection was performed on the returned device as a preservation request, therefore this analysis is considered preliminary.Due to no destructive analysis being performed, the catheter was sent for specialty testing including radiography and microscopic analysis.Specialty analysis revealed that the pebax tubing presented a helical twist which is consistent with clockwise rotation of the catheter handle and the transverse nitinol wire is fractured and the blue pebax material is twisted consistent with torsional loading.A kinked portion within the shaft of the catheter was observed with x-ray imaging, which correlates with the nitinol wire fracture surface which appears macroscopically flat and perpendicular to the wire axis, as well as fractured electrode conductor wires identified distal to the kink.In conclusion, the reported issue of broken shaft has been confirmed through testing.The catheter failed the preliminary returned product inspection due to a broken shaft and loop detachment that remained imbedded within the patient.All analysis was non-destructive.

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 CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4902136
• MDR Text Key: 22388392
• Report Number: 9612164-2015-01229
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

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: 01/31/2017
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 209214035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/11/2015
• Initial Date FDA Received: 07/09/2015
• Supplement Dates Manufacturer Received: 08/25/2015
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2015
• 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): Required Intervention
• Patient Age: 00065 YR
• Patient Weight: 130