MAUDE Adverse Event Report: Covidien C320LBB Delivery System; CATHETER, PERCUTANEOUS

Model Number	C320LBBS45
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction

• 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--439 ; +1(763)526-9277
• MDR Report Key: 50160939
• Report Number: 2936999-2026-00307
• Device Sequence Number: 9103057
• Product Code: DQY
• UDI-Device Identifier: 00199150070138
• UDI-Public: (01)00199150070138(17)280417(10)013011626A(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 013011626A
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 04/18/2026
• 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: 59 YR
• Patient Sex: Female