MAUDE Adverse Event Report: MEDTRONIC IRELAND DEFLECT; CATHETER, PERCUTANEOUS

Model Number C315S1002

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/27/2018

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 the implant attempt of the lead, air ingress was noted in the introducer and catheter.The air was drawn by using a pigtail catheter and the procedure was completed.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.

• Brand Name: DEFLECT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8332516
• MDR Text Key: 135937251
• Report Number: 9612164-2019-00487
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C315S1002
• Device Catalogue Number: C315S1002
• Device Lot Number: 0009189076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• 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
• Patient Weight: 53