MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG HELICAL XTRSOFT COIL 2X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640HX0206
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	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.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 (30367475) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's 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.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.
Event or Problem Description
The healthcare professional reported that the 2mm x 6cm orbit galaxy helical xtrasoft coil ((b)(4)) was the third coil in the procedure.It was reported that the coil could not be advanced nor retrieved by the physician.The physician pulled the coil and the concomitant microcatheter at the same time.After inspection, it was observed that the coil had become stretched.The physician used another coil to complete the procedure.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(6).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that the 2mm x 6cm orbit galaxy helical xtrasoft coil (640hx0206 / 30367475) was the third coil in the procedure.It was reported that the coil could not be advanced nor retrieved by the physician.The physician pulled the coil and the concomitant microcatheter at the same time.After inspection, it was observed that the coil had become stretched.The physician used another coil to complete the procedure.There was no report of any patient adverse event or 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 and received for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 2mm x 6cm orbit galaxy helical xtrasoft coil was received contained in a pouch.Visual inspection was performed.The hypotube is observed with several kinked areas.No other damages nor anomalies were observed during the visual inspection.Microscopic inspection was performed.Under magnification, the embolic coil is observed to be in stretched condition.Dimensional evaluation of the outer diameter (od) of the device was performed and was confirmed to be within specification.The od of the hypotube was measured to be 0.0127 inch; specification: 0/0130 inch + 0.0000 inch / - 0.0005 inch.Functional evaluation could not be performed as the hypotube was returned with several kinked areas that were noted during the visual inspection.The embolic coil is in stretched condition, which precluded the device from undergoing functional evaluation.A review of manufacturing documentation associated with this lot (30367475) 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.It should be noted that product failure is multifactorial.The instructions for use (ifu) does contain 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 issue documented in the complaint was confirmed.It was reported that during the procedure, the complaint coil was the third coil used; the coil could not be advanced nor retrieved by the physician.As a result, the physician removed the complaint coil and the concomitant microcatheter at the same time.Inspection after removal revealed that the coil had become stretched.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.While the exact cause of the stretched condition of the coil cannot be conclusively determined, it is possible that during the procedure, when the coil was reported as not being able to be advanced nor be retrieved by the physician, it was impeded in the microcatheter and during the attempt to advance / retract the coil, some force may have been inadvertently applied which resulted in the coil becoming stretched.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 2mm x 6cm orbit galaxy helical xtrasoft coil left the manufacturing facility with the embolic coil in stretched condition.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.Updated sections: g.3, g.6.H.2, h.3, h.6, and h.10.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 10 august 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 HELICAL XTRSOFT COIL 2X6
• 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: 12178546
• Report Number: 3008114965-2021-00269
• Device Sequence Number: 909650
• Product Code: KRD
• UDI-Device Identifier: 10886704030720
• UDI-Public: 10886704030720
• 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): 06/27/2021

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: 01/31/2022
• Device Model Number: 640HX0206
• Device Catalogue Number: 640HX0206
• Device Lot Number: 30367475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2021
• Supplement Date Received by Manufacturer: 08/10/2021; 09/21/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/10/2021; 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1