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

Model Number	C315HIS02
Medical Device Problem Codes	Accessory Incompatible (1004); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implant, the left ventricular (lv) lead was placed without immediate difficulty.However, fixation of the lead appeared unstable.The lead was removed and a second lv lead was used.It was noted that movement of the second lv lead appeared inconsistent and an echocardiogram confirmed effusion.The abnormal lead movement was also noted at the time of the first lv lead placement attempt.The patient¿s vital signs remained stable.The second lv lead was implanted and the procedure was continued.The right ventricular (rv) lead was placed using a delivery catheter.While slitting, resistance was encountered with the delivery catheter, and the rv lead became dislodged.The rv lead and catheter were removed from the patient.Upon inspection of the catheter, a potential defect was suspected at the site where resistance had been felt.The catheter was replaced and the rv lead was implanted with a new catheter.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: DEFLECT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 25553957
• Report Number: 9612164-2026-03160
• Device Sequence Number: 16135303
• Product Code: DQY
• UDI-Device Identifier: 00763000160180
• UDI-Public: (01)00763000160180(17)280129(10)0013263877
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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
• Operator of Device: Health Professional
• Device Model Number: C315HIS02
• Device Catalogue Number: C315HIS02
• Device Lot Number: 0013263877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 01/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown