MAUDE Adverse Event Report: Medtronic, Inc. C320LBB Delivery System; CATHETER, PERCUTANEOUS

Model Number	C320LBBS45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure, the catheter was performing as expected during the delivery and deployment of the lead.When the physician slit the catheter, it snapped in half but the remnants were extracted and a hemostat was used to continue to slit the sheath.The lead was stable and was successfully implanted.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.There was an issue with the catheter shaft.The catheter shaft was torn.The shaft of the delivery catheter was spiral slit.The shaft on the hub of the delivery catheter was spiral slit.The septum detached from the hub of the delivery catheter.The septum of the catheter was damaged.Visual analysis of the delivery catheter indicated damage during use.The analyst noted the delivery catheter was returned in two pieces.The slitter was not returned.The septum of the delivery catheter was damaged with the adhesive partially releasing from the hub of the delivery catheter.Slitting started near the centerline on the hub of the delivery catheter.The shaft of the delivery catheter was torn in multiple locations along the shaft of the delivery catheter.The shaft of the delivery catheter was torn/broke at 23.6 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: C320LBB Delivery System
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): Medtronic, Inc.; 8200 coral sea street ne; mounds view,mn
• Manufacturer (Section G): Medtronic, Inc.; 8200 coral sea street ne; mounds view,mn
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50767790
• Report Number: 2182208-2026-51838
• Device Sequence Number: 16056416
• Product Code: DQY
• UDI-Device Identifier: 00199150070138
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/15/2026

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: C320LBBS45
• Device Catalogue Number: C320LBBS45
• Device Lot Number: 013011726A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2026
• 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: 69 YR
• Patient Sex: Female