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

Model Number C315HIS02

Device Problem Mechanical Problem (1384)

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

Event Date 06/13/2019

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, the hemostatic valve detached from the catheter during lead manipulation.The catheter was replaced with a new one to complete the procedure.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the delivery catheter was returned and analyzed.The mechanical operation of the catheter was damaged.Visual analysis of the catheter indicated damage during use.The analyst noted the hemostasis valve did become damaged and lodged in the catheter.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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8782890
• MDR Text Key: 150870755
• Report Number: 9612164-2019-02820
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00613994749925
• UDI-Public: 00613994749925
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K101885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0009710387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2019
• 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