MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 RIST; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	106F-071-100
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that there was "product breakage" with a rist catheter.  after opening the product, a kink was discovered in the middle section.The problem was confirmed after opening and before soaking in the saline solution.The cause was unknown, though it was noted there were no particular problems with the handling. a different catheter was used instead. the patient did not experience any health damage.
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.
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
Additional information received reported the product has a kink in the middle section.The device did not separated.The inner package was reported as usual.
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the rist 071 catheter with dilator was returned for analysis within a shipping box, an open outer carton (24966-01), and an open inner pouch (24966-01).The rist 071 catheter and dilator were returned with their hubs secured to the backing card and with the catheter body within the protective tubing.¿ damage location details: no damage was found with the rist 071 catheter hub or distal tip.The rist 071 catheter body was found kinked at ~43.0cm from the proximal end of the catheter hub.When compared to the approximate location of the protective tubing, the protective tubing was found to be damaged.No breaks or separations were found with the rist 071 catheter.No damage was found with the dilator catheter hub, body, or distal tip.¿ testing/analysis: none 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: RIST
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22124094
• Report Number: 2029214-2025-01283
• Device Sequence Number: 18369383
• Product Code: QJP
• UDI-Device Identifier: 00763000541200
• UDI-Public: (01)00763000541200(17)270730(10)24966-01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211990
• 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): 08/08/2025

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 Model Number: 106F-071-100
• Device Catalogue Number: 106F-071-100
• Device Lot Number: 24966-01
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 07/14/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/19/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown