MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemoptysis (1887); Hemothorax (1896); Cardiac Perforation (2513)

Event Date 01/08/2021

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 cryoablation procedure, the mapping catheter was difficult to insert into the right inferior pulmonary vein (ripv).The balloon catheter was deflated, removed and moved, and a different vein was isolated.When the balloon catheter and mapping catheter were inserted again into the ripv and contrast was injected blood was confirmed to be leaking inside of the pulmonary vein, and a perforation was found.Hemoptysis was noted, and the patient developed a hemothorax.The balloon catheter was inflated and used to occlude the pulmonary vein.A balloon device was used to perform hemostasis.A lower lobectomy was scheduled.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the 990063-020 mapping catheter with lot number 220872879 was returned and analyzed.Visual inspection of the mapping catheter showed the loop was damaged due a kink, distortion, and bulged pebax.The loop was deformed and out of plane as if it was rotated counterclockwise.Clinical issues occurred during the procedure(perforation, hemoptysis and hemothorax).In conclusion, the mapping catheter failed the returned product inspection due to the damaged loop caused by a kink, distortion and bulged pebax.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: ACHIEVE MAPPING CATHETER - 20 MM
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 11195622
• MDR Text Key: 227589601
• Report Number: 9612164-2021-00234
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

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: 10/02/2022
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 220872879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFAPRO28 BALLOON CATHETER; AFAPRO28 BALLOON CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention