MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 640CX0306

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/14/2021

Event Type  malfunction  

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.(b)(6).The initial reporter email address is not available / 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.The product analysis lab reviewed the photo included in the complaint.The observation is documented below.[photo analysis]: the photo of the complaint device showed the embolic coil component of the 3mm x 6cm orbit galaxy complex xtrasoft coil with several stretched sections.It could also be observed that the coil still remains attached to the rest of the device.No other damages were noted in the photo.The reported issue that the 3mm x 6cm orbit galaxy complex xtrasoft coil became unraveled / stretched in the microcatheter is confirmed based on the photo which showed the embolic coil component with several areas where the coil is in stretched condition.The timing of when the embolic coil became stretched as observed in the photo cannot be conclusively determined.A review of manufacturing documentation associated with this lot (30592328) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Further investigation will be performed when the device is returned for evaluation and analysis.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.

Event Description

The healthcare professional reported that during an aneurysm embolization procedure, the 3mm x 6cm orbit galaxy complex xtrasoft coil (640cx0306 / 30592328) became unraveled / stretched in the microcatheter.The physician switched to another coil of a different brand to complete the procedure.There was no report of any patient injury.A photo of the complaint device was included in the complaint file.

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 04-jan-2022.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.

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 aneurysm embolization procedure, the 3mm x 6cm orbit galaxy complex xtrasoft coil (640cx0306 / 30592328) became unraveled / stretched in the microcatheter.The physician switched to another coil of a different brand to complete the procedure.There was no report of any patient injury.A photo of the complaint device was included in the complaint file.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.The product analysis lab reviewed the photo included in the complaint.The observation is documented below.Photo analysis: the photo of the complaint device showed the embolic coil component of the 3mm x 6cm orbit galaxy complex xtrasoft coil with several stretched sections.It could also be observed that the coil still remains attached to the rest of the device.No other damages were noted in the photo.The reported issue that the 3mm x 6cm orbit galaxy complex xtrasoft coil became unraveled / stretched in the microcatheter is confirmed based on the photo which showed the embolic coil component with several areas where the coil is in stretched condition.The timing of when the embolic coil became stretched as observed in the photo cannot be conclusively determined.A review of manufacturing documentation associated with this lot (30592328) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The complaint product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 3mm x 6cm orbit galaxy complex xtrasoft coil was received contained in a pouch.Visual inspection was performed.The embolic coil component was observed severely stretched, which is consistent with the damage observed in the photo provided in the complaint.The introducer component was missing; it was not returned.No other damages were observed.Microscopic inspection was performed.Under magnification, the embolic coil was found broken off near the headpiece.The headpiece was still inside the gripper.In the photo provided, it can be observed that the embolic coil was still attached to the rest of the device, however, the returned complaint device had the embolic coil broken off near the headpiece.The observed break appears to be caused by an excessive force exerted on it, however, the exact time when this occurred cannot be determined.The introducer component was not included with the returned device; as a result, further investigation cannot be performed to determine possible causes of the stretched condition of the embolic coil.A manufacturing record evaluation was performed and no non-conformances related to the complaint were found during the review.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that failure could be caused by multiple factors, however the instructions for use (ifu) contains the following precautions: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.The complaint documented that during an aneurysm embolization procedure, the 3mm x 6cm orbit galaxy complex xtrasoft coil became unraveled / stretched in the microcatheter.Based on the condition of the returned device with the embolic coil component observed under visual and microscopic inspections, the reported issue is confirmed.Coil unraveling / stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling for the device to prevent such issue from occurring.The embolic coil can become unraveled or stretched during attempts to withdraw it against resistance.Additional information related to the procedure and the reported device issue was not obtainable.The exact cause of the reported issue cannot be conclusively determined.Assignment of root cause for the event remains speculative and inconclusive.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 3mm x 6cm orbit galaxy complex xtrasoft coil left the manufacturing facility with the embolic coil in stretched condition and separated from the headpiece as observed during the microscopic inspection.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 CMPLX XTRASOFT COIL 3X6
• Type of Device: 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 ; 949789-868
• MDR Report Key: 12929282
• MDR Text Key: 282392551
• Report Number: 3008114965-2021-00575
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704030591
• UDI-Public: 10886704030591
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 640CX0306
• Device Catalogue Number: 640CX0306
• Device Lot Number: 30592328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 02/04/2022
• Supplement Dates FDA Received: 01/04/2022; 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1