MAUDE Adverse Event Report: COVIDIEN RAPIDCROSS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Catalog Number	A14BX030210170
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure to treat 100% plaque stenosis in the mid right superficial femoral artery, a leak was observed at the hub/leur of the rapidcross percutaneous transluminal angioplasty 3.0mm x 210mm x 170cm balloon and a leak was observed at the shaft of the rapidcross percutaneous transluminal angioplasty 3.5mm x 210mm x 170cm balloon.Artery diameter reported as 6mm.The procedure involved the use of a 6fr 45cm non-medtronic (terumo destination) sheath, a 5mm spider fx embolic protection device/guidewire.The vessel was not pre-dilated but was post-dilated using a nanocross 5 x 200 device.Balloon inflation was performed with a non-medtronic (merit) inflation device using 50/50 contrast.Both devices were safely removed from the patient, and the procedure was completed using a new medtronic device.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: the balloon was inflated but wouldn¿t hold pressure and water was seen leaking out through the outer shaft distal to the rx joint, a visual inspection found a hole on the outer shaft distal to the rx joint.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: RAPIDCROSS
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23530752
• Report Number: 2183870-2025-00522
• Device Sequence Number: 10167378
• Product Code: LIT
• UDI-Device Identifier: 00763000756864
• UDI-Public: (01)00763000756864(17)280710(10)C141612(20)05
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142654
• 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): 11/12/2025

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 Catalogue Number: A14BX030210170
• Device Lot Number: C141612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown