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)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
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¿ 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 (30337729) 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 during the procedure, the 2mm x 6cm orbit galaxy helical xtrasoft coil ((b)(4)) was the second coil used; the coil could not be advanced nor retrieved by the physician.As a result, the physician removed the coil and the concomitant microcatheter at the same time.After inspection post removal, the coil was observed to be in stretched condition.The physician used another 42mm x 6cm orbit galaxy helical xtrasoft coil to complete the procedure.There was no report of any patient adverse event, or complication.
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 returned complaint device on 12/11/2020.The returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that during the procedure, the 2mm x 6cm orbit galaxy helical xtrasoft coil (640hx0206 / 30337729) was the second coil used; the coil could not be advanced nor retrieved by the physician.As a result, the physician removed the coil and the concomitant microcatheter at the same time.After inspection post removal, the coil was observed to be in stretched condition.The physician used another 42mm x 6cm orbit galaxy helical xtrasoft 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 for evaluation.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, and the returned device was observed in good condition without any appearance of damage.Microscopic inspection was performed.The embolic coil was observed in good condition.Functional analysis: a lab sample microcatheter was flushed with a lab sample syringe.The returned device was introduced into the microcatheter and the coil was advanced without any resistance or friction felt.A review of manufacturing documentation associated with this lot (30337729) 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 complaint documented that during the procedure, the 2mm x 6cm orbit galaxy helical xtrasoft coil could not be advanced nor retrieved.The physician removed the coil and post-removal, the coil was observed stretched.The reported issues were not confirmed.The returned device was tested and was advanced and retracted without any resistance friction; the embolic coil was observed to be in good condition under 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 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: 10872364
• Report Number: 3008114965-2020-00500
• Device Sequence Number: 3005434
• 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
• Report Date (Section B): 11/03/2020

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: 11/30/2021
• Device Model Number: 640HX0206
• Device Catalogue Number: 640HX0206
• Device Lot Number: 30337729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1