MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X8; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0408
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during the endovascular coiling procedure, the 4mm x 8cm orbit galaxy complex xtrasoft coil (640cx0408 / 30329331) became stretched during placement in the target aneurysm.The coil was removed without any intervention and another coil was used as replacement and the procedure was successfully completed.There was no report of any patient adverse event or complication.The patient is reported as doing fine.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.The initial reporter phone: (b)(6).The initial reporter email address was not reported.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.A review of the manufacturing documentation associated with this lot (30329331) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that multiple attempts have been made to obtain additional information and to obtain the product for analysis were unsuccessful; the product investigation will be closed as no further investigation can be performed at this time.If the product is returned or additional information is provided at a later date, the file will be updated and a supplemental 3500a report will be submitted.[conclusion]: the healthcare professional reported that during the endovascular coiling procedure, the 4mm x 8cm orbit galaxy complex xtrasoft coil (640cx0408/30329331) became stretched during placement in the target aneurysm.The coil was removed without any intervention and another coil was used as replacement and the procedure was successfully completed.There was no report of any patient adverse event or complication.The patient is reported as doing fine.Multiple attempts to obtain additional information related to the procedure, the reported device issue, and to obtain the product for analysis were unsuccessful.If additional information is available at a later date and the product is returned, the file will be updated accordingly.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (30329331) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Attempts to obtain additional information on the reported issue encountered was unsuccessfully.The exact cause of the observed condition of the returned device / coil could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the endovascular coiling procedure, the 4mm x 8cm orbit galaxy complex xtrasoft coil (640cx0408 / 30329331) became stretched during placement in the target aneurysm.The coil was removed without any intervention and another coil was used as replacement and the procedure was successfully completed.There was no report of any patient adverse event or complication.The patient is reported as doing fine.On 19-nov-2021, the complaint product was returned and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 4mm x 8cm orbit galaxy complex xtrasoft coil was received contained in a pouch.Visual inspection was performed.The hub was observed broken.The gripper is kinked and is protruding from the introducer.The introducer is observed split at the protruded section.No other damages nor anomalies were observed during the visual inspection.Microscopic inspection: the 4mm x 8cm orbit galaxy complex xtrasoft coil was inspected under the microscope.The embolic coil component is observed to be in stretched condition inside the introducer.No other damages nor anomalies were observed during the microscopic inspection.A review of the manufacturing documentation associated with this lot (30329331) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint documented that during the procedure, the complaint coil became stretched during placement in the target aneurysm.During visual inspection of the returned complaint device, the hub was observed broken.This could be a result of excessive force applied during the attachment of the rotating hemostasis valve (rhv) to the hub; however, this cannot be conclusively determined.The gripper was also observed kinked and protruding from the introducer; the introducer is split at this area.Procedural and other factors may have contributed to the finding and may be related to the reported issue in the complaint.However, this cannot be conclusively determined.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: if coil repositioning in the vasculature is required, verify under fluoroscopy that a one-to-one relationship exists between the delivery tube and the coil during retraction.Although the coil is stretch resistant, failure of the delivery tube and the coil to retract at the same rate indicates that the coil may have stretched which could lead to premature detachment or coil fracture.If a one-to-one relationship does not exist, remove the infusion catheter and the coil as an assembly and replace.If desired placement or stability cannot be achieved, the coil must be removed from the patient.Under microscopic magnification, the embolic coil is observed stretched inside the introducer.This confirmed the reported issue in the complaint that the coil became stretched during placement in the target aneurysm.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue from occurring.It is possible that circumstances of the procedure and / or device manipulation / interaction may have resulted in the coil stretching during the attempt to place it in the target aneurysm.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 19-nov-2021.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: OG CMPLX XTRASOFT COIL 4X8
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12241169
• Report Number: 3008114965-2021-00310
• Device Sequence Number: 4447740
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: 10886704030638
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/13/2021

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: 10/31/2021
• Device Model Number: 640CX0408
• Device Catalogue Number: 640CX0408
• Device Lot Number: 30329331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 09/21/2021; 11/19/2021; 12/13/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 09/21/2021; 11/19/2021; 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2019
• 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