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

Model Number MI2355A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2018

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 use, the introducer was inserted into the patient's anatomy, the wire and dilator were removed.Aspiration and flush was performed per the protocol.Upon aspiration, air bubbles were coming into the tubing connected to the syringe.The introducer was removed and replaced with another of the same product.Post procedure, saline was flushed through the introducer and no air bubbles were apparent in the tubing connected to the syringe, however air bubbles were witnessed when aspirating blood in the body.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the proximal portion of the introducer was returned and analyzed, and no anomalies were found.Visual analysis of the lead indicated damage during use.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7638879
• MDR Text Key: 112368578
• Report Number: 9612164-2018-01544
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00643169359888
• UDI-Public: 00643169359888
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: 00128616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 88 YR