MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG HELICAL XTRSOFT COIL 2X8; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640HX0208
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, two (2) coils were delivered to the microcatheter ¿smoothly,¿ then the physician delivered the third coil, a 2mm x 8cm orbit galaxy helical xtrasoft coil (640hx0208 / 30615107) to the microcatheter but felt some resistance.The physician then tried to retract the coil; the coil was still impeded in the microcatheter.After several attempts, the physician retracted the coil and observed that it had become unraveled / stretched.A new coil was used as replacement with the same original microcatheter to complete the procedure.There was no report of any patient injury.Two photos of the complaint device was included in the complaint.One of the device packaging and one of the complaint device.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.The 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.The product analysis lab reviewed the photo included in the complaint.The review is documented below.[photo review]: two photos were included in the complaint.In one photo, only the device outer package was shown.In the other photo, a rotating hemostasis valve (rhv) was shown and one portion of the coil was noted to protrude from it; a stretched area was noted.The rest of the device could not be evaluated in the photo.A review of manufacturing documentation associated with this lot: (30615107) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Both allegations were confirmed based on the stretched condition noted in the coil; this condition may be the result of the impeded condition felt during the procedure.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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.(b)(4).The purpose of this mdr submission is to include the additional event information received on 14-dec-2022.[additional information]: on 14-dec-2022, additional information was received indicating that multiple attempts were made 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.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 was received in the product analysis lab on 05-jan-2023.The returned product is pending evaluation.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.
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 an endovascular embolization procedure, two (2) coils were delivered to the microcatheter ¿smoothly,¿.Then the physician delivered the third coil, a 2mm x 8cm orbit galaxy helical xtrasoft coil (640hx0208 / 30615107) to the microcatheter but felt some resistance.The physician then tried to retract the coil; the coil was still impeded in the microcatheter.After several attempts, the physician retracted the coil and observed that it had become unraveled / stretched.A new coil was used as replacement with the same original microcatheter to complete the procedure.There was no report of any patient injury.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.Two photos of the complaint device was included in the complaint.One of the device packaging and one of the complaint device.The product analysis lab reviewed the photo included in the complaint.The review is documented below.[photo review]: two photos were included in the complaint.In one photo, only the device outer package was shown.In the other photo, a rotating hemostasis valve (rhv) was shown and one portion of the coil was noted to protrude from it; a stretched area was noted.The rest of the device could not be evaluated in the photo.A review of manufacturing documentation associated with this lot (30615107) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Both allegations were confirmed based on the stretched condition noted in the coil; this condition may be the result of the impeded condition felt during the procedure.This investigation was performed based only on the photo provided.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 2mm x 8cm orbit galaxy helical xtrasoft coil was received contained in the decontamination pouch.Visual inspection was performed.The embolic coil component was observed out of the introducer and in severely stretched condition.Microscopic inspection was performed.The embolic coil was observed still attached to the gripper component.The blue fiber was exposed.The introducer was inspected and was observed to be in normal good condition.No other damages nor anomalies were observed during the microscopic inspection.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 issues from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The appearance of the returned device confirms the allegation regarding the coil impeding and becoming unraveled / stretched.It is possible that continuous flush had not been maintained during the procedure.Without an adequate flush, issues such as resistance between the coil and the microcatheter can arise, which may have caused some force to be inadvertently exerted on the device when the coil was pushed and then retracted, which can result in the coil becoming stretched.With the limited information available, a conclusive cause cannot be determined; factors not described within the information provided may have contributed to the issue observed.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.If repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.Based on the manufacturing documentation 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.

• Brand Name: OG HELICAL XTRSOFT COIL 2X8
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 15919349
• Report Number: 3008114965-2022-00756
• Device Sequence Number: 4397444
• Product Code: KRD
• UDI-Device Identifier: 10886704030737
• UDI-Public: 10886704030737
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/11/2023

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: 06/30/2023
• Device Model Number: 640HX0208
• Device Catalogue Number: 640HX0208
• Device Lot Number: 30615107
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 12/14/2022; 01/05/2023; 01/11/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 12/15/2022; 01/05/2023; 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• 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
• Patient Sex: Unknown