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

Model Number	640CX0306
Medical Device Problem Codes	Stretched (1601); Failure to Advance (2524); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are 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.A review of manufacturing documentation associated with this lot (30432545) 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.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 or Problem Description
The healthcare professional reported that the 3mm x 6cm orbit galaxy complex xtrasoft coil (640cx0306 / 30432545) could not be advanced nor retrieved by the physician.The physician removed the coil and the microcatheter at the same time and after inspection, the coil was observed to be in stretched condition.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: pc-(b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 28 may 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.
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 the 3mm x 6cm orbit galaxy complex xtrasoft coil (640cx0306 / 30432545) could not be advanced nor retrieved by the physician.The physician removed the coil and the microcatheter at the same time and after inspection, the coil was observed to be in stretched condition.There was no report of any patient adverse event or complication.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 3mm x 6cm orbit galaxy complex xtrasoft coil was received contained in a pouch.Visual inspection was performed and the device was observed to be in good, normal condition without any appearance of damage nor anomaly.Microscopic inspection was performed.The embolic coil was observed in stretched condition inside the coil introducer.No additional damage nor anomaly was observed during the microscopic inspection.Functional evaluation was precluded because the embolic coil was inside the coil introducer in stretched condition.A review of manufacturing documentation associated with this lot (30432545) 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.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint documented that the 3mm x 6cm orbit galaxy complex xtrasoft coil could not be advanced nor retrieved by the physician during the procedure.When the physician removed the coil and the concomitant microcatheter, the coil was observed in stretched condition.The reported issue was confirmed during the microscopic inspection performed on the returned device.The embolic coil was observed stretched inside the coil introducer.The issue related to the coil being impeded in the microcatheter and the resistance friction that resulted in the coil not being able to be advanced nor retrieved could not be confirmed through functional evaluation as the condition of the coil being stretched and inside the introducer precluded functional evaluation.It should be noted that product failure is multifactorial.The instructions for use (ifu) does contain the following precautions: 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.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.Coil stretching is a known potential issue associated with the use of this device.The 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.The complaint documented that the coil could not be advanced nor retrieved; it was impeded in in the microcatheter.When it was removed, it was observed stretched.It is likely that during the attempt to advance and retrieve the coil, some force was applied which resulted in the reported stretched condition.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 3mm x 6cm orbit galaxy complex xtrasoft coil left the manufacturing facility with the embolic coil in the stretched state 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.H.6: the investigation findings code of ¿no device problem found (c19)¿ is related to the reported failure to advance and difficult to advance issues.The condition of the returned device precluded the functional evaluation for these two issues.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
• 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: 11800263
• Report Number: 3008114965-2021-00172
• Device Sequence Number: 1020486
• Product Code: KRD
• UDI-Device Identifier: 10886704030591
• UDI-Public: 10886704030591
• 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,Followup,Followup
• Report Date (Section B): 04/20/2021

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: 07/31/2022
• Device Model Number: 640CX0306
• Device Catalogue Number: 640CX0306
• Device Lot Number: 30432545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 05/28/2021; 05/29/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/28/2021; 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1