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

Catalog Number	A14BX025210170
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
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
A physician used a rapidcross percutaneous transluminal angioplasty balloon to treat a calcified lesion in the left mid anterior tibial artery below the knee.A 6fr sheath was used.The balloon was inflated with a 50/50 contrast solution using a non-medtronic inflation device.No resistance was encountered when advancing the device.The vessel was post-dilated.The balloon was used and successfully went up and deflated to treat the at.It was reported that the balloon detached from the catheter shaft and was left in the superficial femoral artery.Imaging was performed, including a picture taken to confirm the balloon's location in the superficial femoral artery.The procedure was extended after the physician realized that the balloon was no longer attached to catheter shaft.Two open cell stents were deployed into the superficial femoral artery to compress the balloon against the arterial wall.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information received reported that the balloon catheter did not catch upon the sheath during withdrawal.The device was further distal (up/down) for balloon.It was caught on calcium or the wire according to our customer.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.
Additional Manufacturer Narrative
Product analysis: the device was received with the distal end of the shaft and balloon detached.The detachment occurred approximately 139cm from the strain relief.There is stretching evident on the proximal end of the shaft.The detached section was not returned.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: 22815895
• Report Number: 2183870-2025-00395
• Device Sequence Number: 5738562
• Product Code: LIT
• UDI-Device Identifier: 00763000756703
• UDI-Public: (01)00763000756703(17)280415(10)C083973(20)05
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 10/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A14BX025210170
• Device Lot Number: C083973
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 09/24/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/11/2025; 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male