MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHERA; CATHETER, CONTINUOUS FLUSH

Model Number	FG11150-0615-2S
Medical Device Problem Codes	Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 information that a phenom17 catheter inner coating was damaged.Catheter inner coating was broken and microwire cannot be enter.The devices were prepared according to the instructions for use (ifu).The catheter was flushed as per ifu.  the patient was being treated for an aneurysm.The access vessel was the internal carotid artery (ica).No patient symptoms or complications were reported.
Additional Manufacturer Narrative
H3: product analysis of fg11150-0615-2s, lotno:226898745, as found condition: the phenom 17 catheter was returned within the outer carton, inside of a sealed bio-hazard bag and a shipping box.The microwire was not returned with the catheter.In addition, the microwire size and model were not reported.Therefore, any contribution from the microwire including its compatibility for use with the catheter, could not be assessed.Visual inspection/damage location details: the catheter tip, marker, and body were examined; no damages were found, and no other anomalies were observed.Testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed with water and found patent.It was then tested by running an in-house 0.016¿ mandrel through the catheter hub.The mandrel successfully passed through the catheter hub, lumen, and tip without issue.No inner coating damage was observed.Conclusion: based on the returned device, the customer complaint was not confirmed, as no issue was found with the returned catheter.The in-house mandrel could pass through the catheter hub, lumen, and tip without issue.The cause could not be determined.A possible cause includes the use of damaged/incompatible microwire.Since the microwire was not returned, any contribution of the microwire to the reported issue 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.
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 microwire was chikai black.There was no damage to the inner coating.

• Brand Name: CATHERA
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 19226408
• Report Number: 9612164-2024-02090
• Device Sequence Number: 18232815
• Product Code: KRA
• UDI-Device Identifier: 00763000399665
• UDI-Public: 00763000399665
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151638
• 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): 07/16/2024

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: 07/05/2026
• Device Model Number: FG11150-0615-2S
• Device Catalogue Number: FG11150-0615-2S
• Device Lot Number: 226898745
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 05/24/2024; 06/20/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/19/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown