MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number	RFX072-105-08MP
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2024
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
Medtronic received a report that when the operator opened the catheter, he found that the front end of the catheter was broken, making it unusable.After replacing with the same model of catheter during the operation, the operation was completed.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.There was no patient involved in the event.Additional information was received that the catheter was not completely separated, just partially connected.There was no damage or evidence of tampering to device packaging.Additional information was received that the break was located in the distal section of the catheter.

• Brand Name: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19340758
• Report Number: 2029214-2024-00935
• Device Sequence Number: 15651485
• Product Code: DQY
• UDI-Device Identifier: 00847536017887
• UDI-Public: 00847536017887
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110055
• 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): 05/17/2024

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: 12/14/2024
• Device Model Number: RFX072-105-08MP
• Device Catalogue Number: RFX072-105-08MP
• Device Lot Number: B492682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2024
• Initial Report FDA Received Date: 05/17/2024
• Date Device Manufactured: 12/15/2022
• 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
• Patient Sex: Unknown