MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG HELICAL XTRSOFT COIL 2X4; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640HX0204
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.
Event or Problem Description
As reported by the field, during a coil embolization, a 2x4 orbit galaxy coil (640hx0204, 30571045) became unraveled/stretched in the unspecified microcatheter (mc).The physician switched to a new one to complete the surgery.There was no patient injury report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicated that the coil became unraveled/stretched during advancement.There was resistance encountered prior to the coil unraveling.Prior to this coil, other coils were able to be advanced through the same microcatheter.There was no blood flow restriction/reduction as a result of the event.Adequate flush was maintained through the devices.There were no procedural delays due to the event.The procedure was to the ophthalmic artery segment.The aneurysm size was 3x4.Complaint conclusion: as reported by the field, during a coil embolization, a 2x4 orbit galaxy coil (640hx0204, 30571045) became unraveled/stretched in the unspecified microcatheter (mc).The physician switched to a new one to complete the surgery.There was no patient injury report.Additional information received indicated that the coil became unraveled/stretched during advancement.There was resistance encountered prior to the coil unraveling.Prior to this coil, other coils were able to be advanced through the same microcatheter.There was no blood flow restriction/reduction as a result of the event.Adequate flush was maintained through the devices.There were no procedural delays due to the event.The procedure was to the ophthalmic artery segment.The aneurysm size was 3x4.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30571045 number, and no non-conformances related to the malfunction were identified.Coil unraveling/stretching is indicative of the application of excessive force, possibly in an attempt to overcome the reported resistance.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing record evaluation (mre), there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: OG HELICAL XTRSOFT COIL 2X4
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14469082
• Report Number: 3008114965-2022-00357
• Device Sequence Number: 19959445
• Product Code: KRD
• UDI-Device Identifier: 10886704030713
• UDI-Public: 10886704030713
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 03/31/2023
• Device Model Number: 640HX0204
• Device Catalogue Number: 640HX0204
• Device Lot Number: 30571045
• 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: 05/07/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED MICROCATHETER
• Patient Sex: Unknown