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

Model Number	C315S502
Medical Device Problem Codes	Accessory Incompatible (1004); Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
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 the implantable pacing lead (ipl) was placed as needed and during the delivery catheter slitting process, the cut was not smooth and damage occurred midway.The ipl was noted to have dislodged during the delivery catheter slitting.A new delivery catheter, and slitter was used to implant a new lead.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the delivery catheter was returned and analyzed.The shaft on the hub of the delivery catheter was spiral slit.The shaft of the delivery catheter was spiral slit.The peeling/slitting/splitting was not slit on the center of hub of the delivery catheter.Visual analysis of the delivery catheter indicated damage during use.The analyst noted the delivery catheter was returned without the dilator.Slitting did not start on the centerline on the hub of the delivery catheter.The hub of the delivery catheter was spiral slit.The shaft of the delivery catheter was spiral slit.Slitting had terminated at 9.9 cm.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.

• 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: 23791375
• Report Number: 9612164-2025-06163
• Device Sequence Number: 5712321
• Product Code: DQY
• UDI-Device Identifier: 00763000160227
• UDI-Public: (01)00763000160227(17)270623(10)0012883705
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: C315S502
• Device Catalogue Number: C315S502
• Device Lot Number: 0012883705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 78 KG