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

Model Number	106F-071-95
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis # (b)(4): ¿ equipment used: vis (m-78210), 203cm ruler (m-83361) ¿ drawing(s) referenced: none ¿ as found condition: the rist 071 catheters (pli-10/20) were returned for analysis within a shipping box and a plastic bio-pouch.¿ damage location details: (pli-10) no damages were found with the rist 071 catheter hub.The rist 071 catheter body was found broken at the strain relief ~4.0cm from the proximal end of the catheter hub, retained by the inner wire.The rist 071 catheter body was found kinked at ~65.5cm, ~50.0cm, ~36.0cm, and ~34.0cm from the catheter distal tip.The rist 071 catheter distal tip was found ovalized.(pli-20) no damages were found with the rist 071 catheter hub.The rist 071 catheter body was found broken at the strain relief ~4.0cm from the proximal end of the catheter hub, retained by the inner wire.The rist 071 catheter body was found kinked at ~90.5cm, ~84.5cm, ~80.0cm, ~75.5cm, ~64.5cm, ~56.5cm, ~48.0cm, ~43.4cm, ~40.0cm, and ~29.5cm from the catheter distal tip.The rist 071 catheter distal tip was found ovalized.¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿catheter separation/break¿ report was confirmed.The returned rist 071 catheters (pli-10/20) were found broken at the strain relief.In addition, the returned rist 071 catheters were found kinked with the distal tips ovalized.Damage can occur due to an impact from an unknown source prior to being opened, damage during storage, use-related, or manufacturing-related (e.G., operator handling damage, missed inspection).However, the cause of the catheter damage could not be determined.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
It was reported that the hub was not attached to the catheter for the catheter radial guide 106f-071-95.This issue occurred twice when the physician removed the 6f rist catheter from the packaging and noticed the hub was not attached.The physician discarded the first unit, opened another from the same lot, and encountered the same issue.Neither device was used in the procedure, and the physician opted to utilize a competitive guide sheath to complete the case.There was no patient involved.Additional information was received that there was no damage or evidence of tampering to device packaging.

• Brand Name: RIST
• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 21713469
• Report Number: 2029214-2025-00794
• Device Sequence Number: 10010835
• Product Code: DQY
• UDI-Device Identifier: 00763000541194
• UDI-Public: 00763000541194
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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-071-95
• Device Catalogue Number: 106F-071-95
• Device Lot Number: 25547-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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