MAUDE Adverse Event Report: COVIDIEN C320LBB DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	C320LBBL45
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during implant that after successful placement of the lead in the left bundle area, during slitting, the sealing ring of the catheter was not cut and remained around the lead body which resulted to the lead dislodgement.The catheter was attempted but not used and replaced.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.Analysis indicated the septum detached from the hub of the delivery catheter.The slitting was not slit on the center of hub of the delivery catheter.The shaft on the hub of the delivery catheter was spiral slit.The shaft of the delivery catheter was spiral slit.The analyst noted the catheter and the slitter were returned, but the lead was not.Visual analysis showed there was adhesive bond present in the hub of the delivery catheter, but the septum was detached from the hub and not returned.Slitting was completed from the hub to the distal end of the catheter.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: C320LBB DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 6135 gunbarrel ave; boulder,co
• Manufacturer (Section G): COVIDIEN; 6135 gunbarrel ave; boulder,co
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 25230270
• Report Number: 2936999-2026-00190
• Device Sequence Number: 14729687
• Product Code: DQY
• UDI-Device Identifier: 00763000747459
• UDI-Public: (01)00763000747459(17)280114(10)745010326B(20)01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K253409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: C320LBBL45
• Device Catalogue Number: C320LBBL45
• Device Lot Number: 745010326B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2026
• 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
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 86 KG