MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE ADVANCE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT

Model Number 2ACH20

Device Problems Entrapment of Device (1212); Mechanical Problem (1384)

Patient Problem Physical Entrapment (2327)

Event Date 12/14/2022

Event Type  Injury  

Event Description

It was reported that after a successful cryo ablation procedure, the balloon catheter and mapping catheter were removed from the body.The physician chose to insert the mapping catheter again to perform electrophysiology (ep) studies.When advancing the mapping catheter there was resistance and upon fluoroscopy there was no visible reason for the resistance.It was then noted that the mapping catheter could not be advanced or retracted.Upon further fluoroscopy, the mapping catheter appeared to be stuck on something in the inferior vena cava (ivc) and the lumen appeared dilated as if it had been stretched.Further attempts to advance or retract the mapping catheter were not successful.It was then attempted to remove the sheath and the mapping catheter together and on fluoroscopy it was noted that the mapping catheter was further stretched.A j-tip guidewire from another manufacture was inserted and the sheath was pulled back in an attempt to remove the mapping catheter which was not successful.The sheath was able to be removed with the guidewire.Then the physician was able to hold the mapping catheter handle via the groin access point on the patient and it was removed directly from the groin.There was no patient injury noted.A groin venogram was performed at the end of the case to confirm that no vessel damage had occurred at the site where the mapping catheter was stuck or near the groin.The case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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.

Manufacturer Narrative

Product event summary: the date files and the 2ach20 mapping catheter with lot 7431407 were returned and analyzed.There were no data files returned for the event date, and the returned files were corrupted.The failure files did not show any system notices triggered on the event date.The reported issue cannot be assessed through data analysis.Visual inspection was performed on the mapping catheter, and a ribbed material was observed on the tubing, and a broken shaft was observed.Visual inspection of the tubing segment area showed the tubing was ribbed distal to the tubing and shaft bond.A visual inspection of the shaft segment area was performed and showed the shaft was broken proximal to the tubing bond and one of the ecg (electrocardiogram) signal wires was broken.In conclusion, the mapping catheter failed the returned product inspection due to ribbed material on the tubing, and a broken shaft.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 ADVANCE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16039461
• MDR Text Key: 306062593
• Report Number: 2182208-2022-04133
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2023

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 Model Number: 2ACH20
• Device Catalogue Number: 2ACH20
• Device Lot Number: 7431407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male