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

Model Number	C315HIS02
Medical Device Problem Code	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
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that intra operatively during the placement of the left bundle branch lead, the physician failed to rotate it into the proper position when operating the 3830 lead despite multiple attempts.Upon removing the lead, excessive connective tissue was observed at its tip, therefore the tissue was cleared, and the lead was re-secured.The testing parameters were normal but after the sheath was cut, subsequent testing revealed changes in the multi-lead electrocardiographic waveforms.A new catheter was used for implant of the lead.Shortly, it was discovered that the helical screw at the lead tip had become deformed.Therefore, the lead was attempted not used.No patient complications have been reported as a result of this event.

• 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: 25482300
• Report Number: 9612164-2026-03032
• Device Sequence Number: 10513233
• Product Code: DQY
• UDI-Device Identifier: 00763000160180
• UDI-Public: (01)00763000160180(17)270404(10)0012752116
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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: 0012752116
• 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: 06/12/2026
• Date Device Manufactured: 04/04/2025
• 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
• Patient Sex: Unknown