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

Model Number 990063-015

Device Problems Entrapment of Device (1212); Knotted (1340)

Patient Problems Hemoptysis (1887); Tissue Damage (2104)

Event Date 10/25/2016

Event Type  malfunction  

Event Description

It was reported that during a cryoablation procedure, the mapping catheter was deep in the right superior pulmonary vein (rspv) and after the return maneuver; the catheter was in the form of a node.It was further reported that the mapping catheter could not be drawn into the sheath and balloon catheter; only with great strength could the mapping catheter be withdrawn from the heart.It was noted that venous epithelium from the left superior pulmonary vein (lspv) was present on the mapping catheter and after return of the catheter, the patient aspirated blood from the lungs.The procedure was aborted, the patient was intubated and a bronchoscopy was performed.Additional information received confirmed the patient has no injury.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files did not show system notices or issues for the date of the event.Physical product analysis is pending.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the mapping catheter was returned and analyzed.Visual inspection showed that the shaft was broken at 12 inches distal from the ecg connector.No ecg signal wires were broken inside the shaft.It was also seen that the tip/ loop section was damaged.All 8 electrodes exist on the loop section but 3 of them were displaced.The balloon catheter was also visually inspected and issues were found unrelated to this report.Hemoptysis, tissue damage and catheter entrapment in the heart are clinical issues that were encountered during the procedure.In conclusion, the reported issue was confirmed through testing.The achieve catheter failed the returned product inspection due to a broken shaft and damaged tip/ loop section.

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 MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6109600
• MDR Text Key: 60236800
• Report Number: 9612164-2016-01175
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/16/2017
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Device Lot Number: 0007505173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 12/16/2016
• Supplement Dates FDA Received: 12/08/2016; 12/08/2016; 01/13/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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 Age: 66 YR
• Patient Weight: 80