MAUDE Adverse Event Report: MEDTRONIC MEXICO ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that prior to a cryo ablation procedure, the mapping catheter shaft was noted to be kinked when it was removed from the packaging.The mapping catheter was replaced.There was no patient involvement.

Manufacturer Narrative

Product event summary: the mapping catheter 990063-020 with lot number 219586406 was returned and analyzed.Visual inspection of the mapping catheter was performed.Visual inspection of the pebax segment area was also performed.Inspection identified a pebax tubing kink/twist at 7.5 inches from the tip of the shaft.The user may have experienced insertion difficulties due to this issue when introducing the achieve mapping catheter into the balloon catheter.In conclusion, the reported mapping catheter kink was confirmed though testing.The mapping catheter failed the returned product inspection due to the kink.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; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 10388424
• MDR Text Key: 202410408
• Report Number: 9612164-2020-02936
• 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: 09/18/2020

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: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 219586406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 08/23/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1