MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM HELIX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-2-8-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that there was great resistance of both coils and they were stuck in the sheath and couldn't come out. the reported devices and any accessory devices were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.  the patient was undergoing surgery for treatment of which was unknown.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Additional information received reported during preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
Additional Manufacturer Narrative
Product analysis #(b)(4):equipment used: vis (b)(4), m-203cm ruler (b)(4), pin gauges (b)(4) document used: (b)(4) rev.B, (b)(4) rev.C, (b)(4) rev.E as found condition (condition of returned device): the axium implant coil was returned for analysis within a shipping box; returned within a sealed plastic biohazard pouch; returned within an open axium implant coil inner pouch and within a dispenser coil.Damage location details: the axium implant coil was returned within the introducer sheath which was found to be applied correctly with the wavelock facing towards the proximal end.No damage was found on introducer sheath.The axium implant coil pushwire was found to be broken at ~4.5cm with release wire visible; however, the axium pushwire was also found to be bent at ~7.5cm; kinked at ~69.5cm; kinked at ~71.5cm and bent at ~72.5cm from the proximal end.The axium implant coil was found to be detached prematurely and damaged within the introducer sheath.The axium implant coil was found to be located detached within the introduce sheath near the distal end.The implant coil was not able to be pushed out of introducer sheath due to the resistance and the detachment of the axium implant coil.No other anomalies were observed.Testing/analysis (including sem reports): the axium implant coil tip od (outer diameter) which was found to be.0117¿ which was found to be within in specification (specification.0112¿ +.0010¿/-.002¿).The introducer sheath id (inner diameter) which was measured to be.0185¿ (0.47mm) which was found to be within specification (specification 0.47mm +0.03mm/-0.00mm).Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed; however, the root cause was unable to be determined.The customer reported preparing the axium implant coil as indicated in the ifu prior to use.It is possible insufficient preparation of the axium implant coil, damage during preparation or improper hubbing technique (over tightening of the rhv) could have contributed to the event.Possible causes for coil resistance are, but not limited to, failure to hydrate the coil prior to use, failure to utilize continuous flush and use of an improper hubbing technique (over tightening of the rhv/sheath firmly seated into hub).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM HELIX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 16035195
• Report Number: 2029214-2022-02163
• Device Sequence Number: 12558824
• Product Code: KRD
• UDI-Device Identifier: 00847536037304
• UDI-Public: 00847536037304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2022

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: 04/02/2025
• Device Model Number: QC-2-8-HELIX
• Device Catalogue Number: QC-2-8-HELIX
• Device Lot Number: 224075517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown