MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; INTRODUCER, CATHETER

Model Number MI2355A

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that during implant of a leadless implantable pulse generator (ipg), the introducer valve was broken. when the dilator was slowly pulled out because the sheath went in successfully, the plastic ring part attaching the rubber part of the valve came off and blood leaked out of the valve. a new introducer was used and the procedure was completed. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the introducer was returned and analyzed.The distal seal of the delivery system introducer was torn.The seal cap of the delivery system introducer was damaged.The seal housing of the delivery system introducer was damaged.The analyst noted the introducer was returned with the dilator separated from the sheath of the introducer.The seal cap and proximal seal was returned on the shaft of the dilator upon receipt.The seal cap latches were damaged.The inside of the of the seal body latch holes were damaged.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19003754
• MDR Text Key: 338945569
• Report Number: 9612164-2024-01529
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: 00182567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Date Device Manufactured: 07/21/2023
• 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