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

Model Number 990063-015

Device Problems Device Operates Differently Than Expected (2913); Torn Material (3024)

Patient Problem Vascular Dissection (3160)

Event Date 09/23/2015

Event Type  Injury  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was reported that during a cryoablation procedure, after insertion of the mapping catheter into the right inferior pulmonary vein (ripv), the catheter could not be retracted out of the pulmonary vein (pv).It was noted that the catheter was torn; the physician then decided to cut the end and retract it over the wire with a catheter.The mapping catheter was retracted successfully and the procedure was aborted for safety reasons.Further follow-up indicated that a dissection of the pulmonary vein was noticed when the event occurred, and that the catheter appeared kinked after the successful retraction.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: data files and the device, mapping catheter 990063-015 with lot 209411791, were returned and analyzed.The data files did not show any system notices on the reported date of the event.Upon return, the catheter was inside a competitor sheath for capturing the loop array.Visual inspection of the catheter showed the catheter was broken at the proximal end attachment with the electrocardiogram (ecg) connector; all ecg signal wires were broken inside the shaft.It was noted that this was broken post procedure to introduce the mating device to capture the catheter¿s loop section.Additionally, the loop array was misshapen and the array was damaged; the covering in the array section appeared twisted counterclockwise, in scope with the instructions for use.The pebax tubing was ribbed at multiple locations along the pebax starting at the transition with the metal shaft to the loop array; all eight electrodes exist on the loop section.These product analysis findings do not indicate a manufacturing related defect; the damaged tip/loop section and kink were caused by excessive maneuvering of the catheter to retract it from the entrapment of the pulmonary vein.The dissection of the pulmonary vein and entrapment of the catheter in the heart are clinical issues encountered during the procedure.In conclusion, the kink and damaged loop array of the mapping catheter were confirmed through visual inspection.The mapping catheter failed the return product inspection due to the damaged tip/loop section, kink in the tip/loop section, ribbed pebax tubing, and broken shaft at the ecg connector attachment.Clinical issues of catheter entrapment in the heart and pulmonary vein dissection were 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 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: 5138562
• MDR Text Key: 27912142
• Report Number: 9612164-2015-01624
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Followup,Followup,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Device Lot Number: 209411791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• 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