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

Catalog Number	A14BX030080090
Medical Device Problem Codes	Leak/Splash (1354); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A physician was using a rapid cross pta balloon.It was reported that the  0.014 inch guidewire does not exit through the catheter guidewire port laterally, but exits at the port connected to the inflation lumen distally. when administering saline through the distal inflation port, the operator noticed a leak of saline through the lateral catheter guidewire port.The operator decided to use another balloon of the same reference (b)(4) to complete the procedure successfully.There were no clinical consequences for the patient.No deformation was noted on device.Device was used to treat tight stenosis of the distal superficial femoral artery.When the device was returned for evaluation it was noted that there was a leak from the tip of the device.
Additional Manufacturer Narrative
Product analysis a 0.014¿ guidewire was loaded into the device through the tip and exits at the rx joint as normal, the balloon was inflated but wouldn¿t hold pressure and water was seen leaking out through the tip and rx joint indicating a leak on the inner shaft, 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
Confirmation was received that the device was not used in the patient - no patient involvement and the issue was noted prior to use 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: 19039718
• Report Number: 2183870-2024-00112
• Device Sequence Number: 8548250
• Product Code: LIT
• UDI-Device Identifier: 00763000110949
• UDI-Public: 00763000110949
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 04/05/2024

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 Expiration Date: 04/19/2026
• Device Catalogue Number: A14BX030080090
• Device Lot Number: B551814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/05/2024
• Date Device Manufactured: 04/20/2023
• 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