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

Catalog Number	A14BX040150170
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician was attempting to use rapidcross along a wire (asahi cruise) and 6fr sheath (terumo destination 45cm) for patient treatment. saline and contrast medium, half-and-half was used for inflation fluid.It was reported that deflation difficulties were discovered during the initial inflation phase and it was difficult to remove the device. as balloon deflation could not be performed, it was pulled into the sheath as is and removed together with the sheath while the balloon was contained within the sheath.The procedure was continued.No patient injury reported.Intervention performed: balloon was pulled into the sheath and explanted with the sheath.
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.

• 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 ; +353(091)708096
• MDR Report Key: 50132157
• Report Number: 2183870-2026-00356
• Device Sequence Number: 21461080
• Product Code: LIT
• UDI-Device Identifier: 00763000757168
• UDI-Public: (01)00763000757168(17)270828(10)B780596(20)05
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A14BX040150170
• Device Lot Number: B780596
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/05/2026; 09/03/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 08/10/2026; 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown