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

Model Number C315HIS02

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the delivery catheter was returned and analyzed.Analysis indicated the mechanical operation of the catheter shaft was kinked/buckled.Blood was observed in the hemostasis valve of the delivery catheter.Blood was observed on the shaft of the delivery catheter.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, when the physician inserted the lead into the catheter and moved it to the target location, the lead seemed to get stuck.A kink in the catheter was found during fluoroscopy and the catheter was removed.Upon inspection, a deep kink was found and the catheter broke.A new catheter was used to implant the lead.No patient complications have been reported as a result of this event.

• Brand Name: DEFLECT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10390973
• MDR Text Key: 202403399
• Report Number: 9612164-2020-02951
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00613994749925
• UDI-Public: 00613994749925
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 08/11/2020

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: 02/05/2022
• Device Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0010125835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2020
• 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