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

Catalog Number	A14BX040100170
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
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 during treatment of a calcified plaque lesion in the distal right superficial femoral artery using a rapidcross balloon, the medical staff experienced inflation difficulties as the balloon could not be seen inflating.When attempting to remove the device, it would not pass through the sheath, requiring removal of both the sheath and balloon as a unit.The balloon catheter caught upon the sheath during withdrawal, and the procedure was aborted.The vessel had been pre-dilated, and a 6fr non-medtronic sheath and.014 non-medtronic guidewire were used.Inflation was attempted with a merrit inflation device using 50/50 contrast.The device was removed successfully in tandem without injury or intervention, and no vessel damage was reported.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis the device was received with the distal section of the device detached.The detachment occurred at the rx joint.The detached section was returned in a 6fr sheath, 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: 22494360
• Report Number: 2183870-2025-00369
• Device Sequence Number: 4272982
• Product Code: LIT
• UDI-Device Identifier: 00763000757120
• UDI-Public: (01)00763000757120(17)270514(10)B732142(20)05
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130911
• 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,Followup
• Report Date (Section B): 09/11/2025

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: A14BX040100170
• Device Lot Number: B732142
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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 Age: 49 YR
• Patient Sex: Male