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

Model Number MI2355A

Device Problem Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the implant procedure of the leadless implantable pulse generator (ipg), the operator was unable to aspirate the blood with the syringe from the introducer and only air was extracted.The maneuver was tried multiple times without success.New introducer was used but the same problem remained but it was possible to connect the introducer without visible air in the system.Leadless ipg was implanted and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

Product event summary: the introducer was returned and analyzed.The analysis indicated that the distal seal of the delivery system introducer was torn.The dilator of the delivery system introducer was damaged.Blood was observed on the delivery system introducer distal seal.Blood was observed on the delivery system introducer proximal seal.Visual analysis of the introducer indicated damage during use.The analyst noted the introducer was returned with the dilator separated from the sheath.There is damage on the dilator shaft at 14 cm.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• MDR Report Key: 10761890
• MDR Text Key: 213882776
• Report Number: 9612164-2020-04156
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K132030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

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: 03/13/2021
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: 00139288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/23/2020; 11/16/2020
• Supplement Dates FDA Received: 10/30/2020; 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1