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

Model Number	640CX0408
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that the 4mm x 8cm complex xtrasoft coil (640cx0408 / 30425582) was the first coil used.The physician decided to pull it out for re-deployment after trying another size of coil.During the attempt to resheath the coil, the introducer failed to be re-sheathed.The physician decided to remove the coil due to its size not being appropriate with the target aneurysm.It was reported that the physician used ¿a same like¿ product and the procedure was successfully completed.There was no report of any patient adverse event / complication.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 complaint device was returned for evaluation.During the microscopic inspection of the returned device, the embolic coil was observed stretched and in damaged condition.Based on the product analysis on (b)(6) 2021, this event has been deemed mdr reportable as a ¿malfunction.¿.
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that the 4mm x 8cm complex xtrasoft coil (640cx0408 / 30425582) was the first coil used.The physician decided to pull it out for re-deployment after trying another size of coil.During the attempt to resheath the coil, the introducer failed to be re-sheathed.The physician decided to remove the coil due to its size not being appropriate with the target aneurysm.It was reported that the physician used ¿a same like¿ product and the procedure was successfully completed.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 complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4mm x 8cm complex xtrasoft coil was received contained in a pouch.Visual inspection was performed.It was observed that the introducer was not returned with the rest of the device for evaluation.The hypo-tube was observed to be severely kinked.No other damages nor anomalies were observed during the visual inspection.Microscopic inspection as performed.Under magnification, the embolic coil was observed stretched and in damaged condition.Functional test was precluded due to the introducer component not returned with the rest of the complaint device.A review of the manufacturing documentation associated with this lot (30425582) 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 issue reported in the complaint that the 4mm x 8cm complex xtrasoft coil was the first coil used; the physician decided to pull the coil for re-deployment after trying another size of coil.It was reported that during the attempt to resheath, the introducer failed to be re-sheathed.The issue related to the failure to be re-sheathed could not be confirmed as the introducer component was not returned with the rest of the complaint device.Without the introducer, the returned complaint device could not undergo functional evaluation.The exact time when the introducer became separated from the device is not known; it is possible that it could have occurred after the procedure or at any other point in time during the transportation and the decontamination of the device.At the time of the product investigation, the cause remains unknown.Coil stretching and coil damaged are known potential issues associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issue as stretching from occurring.The stretched and damaged condition of the embolic coil were not originally reported in the complaint.The embolic coil can become stretched and damaged during procedure handling where force may have been inadvertently applied.The exact cause of the observed stretched and damaged condition of the embolic coil could not be conclusively determined; however, it is possible that during the attempt to re-sheath the coil and the introducer failed to be re-sheathed, the device had some force exerted upon it which may have been the contributing factors to the stretched and damaged condition observed during the microscopic inspection.Attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 4mm x 8cm complex xtrasoft coil left the manufacturing facility with the embolic coil in stretched and damaged condition as noted 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.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.

• 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
• MDR Report Key: 12752837
• Report Number: 3008114965-2021-00550
• Device Sequence Number: 17280594
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: 10886704030638
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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: 06/30/2022
• Device Model Number: 640CX0408
• Device Catalogue Number: 640CX0408
• Device Lot Number: 30425582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/04/2021
• Patient Sequence Number: 1