MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3.5X7.5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX3575
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.(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 (30302571) 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 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil (640cx3575 / 30302571) was the first coil used in the procedure.It was reported that the physician could not advance nor retrieve the coil.The physician pulled the coil and the microcatheter (unknown brand) out of the patient.After inspection, the coil was reported to be in stretched condition.The physician replaced the coil with another 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil and the procedure was successfully completed.There was no report of any patient adverse event nor complication associated with the reported device issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr submission is to report that the product was received by the lab on 07/15/2020; the returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that the 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil (640cx3575 / 30302571) was the first coil used in the procedure.It was reported that the physician could not advance nor retrieve the coil.The physician pulled the coil and the microcatheter (unknown brand) out of the patient.After inspection, the coil was reported to be in stretched condition.The physician replaced the coil with another 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil and the procedure was successfully completed.There was no report of any patient adverse event nor complication associated with the reported device issue.Multiple attempts to obtain additional information related to the procedure and the reported device issues 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 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil was returned contained in a pouch.No damage was observed on the device during the visual inspection.Microscopic inspection was performed.Under magnification, the embolic coil was observed in stretched and kinked conditions.It was also observed protruding from the introducer.A review of manufacturing documentation associated with this lot (30302571) 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 reported that during the procedure, the complaint coil was the first coil chosen to be used; the physician could not advance nor retrieve the coil.The physician pulled the coil and the microcatheter out of the patient.After inspection, the coil was reported to be in stretched condition.The issues were confirmed based on the visual and microscopic inspections performed on the returned device.The embolic coil was stretched and kinked, it was also protruding from the introducer which likely caused the coil not to advance not be retracted.Coil stretching and kinking are known potential issues associated with the use of the device.The instructions for use (ifu) provides proper handling instructions for the device to prevent issues such as stretching and kinking from occurring.The exact cause(s) of the observed conditions of the embolic coil on the returned device cannot be conclusively determined; however, the most likely cause is applied excessive force.It is possible that during the attempt to advance and retract the coil during the procedure, the physician may have inadvertently applied force which caused the coil to protrude from the introducer as well as stretching and kinking the coil.Based on the review of the manufacturing documentation, 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 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil left the manufacturing facility with the embolic coil being outside of the introducer in kinked and stretched condition as observed on the returned device.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: d.10, g.4, g.7, 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.

• Brand Name: OG CMPLX XTRASOFT COIL 3.5X7.5
• 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: 10224911
• Report Number: 3008114965-2020-00246
• Device Sequence Number: 595248
• Product Code: KRD
• UDI-Device Identifier: 10886704030706
• UDI-Public: 10886704030706
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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: 08/31/2021
• Device Model Number: 640CX3575
• Device Catalogue Number: 640CX3575
• Device Lot Number: 30302571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1