MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3.5X5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX3505
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 (30367473) 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.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 3.5mm x 5.0cm orbit galaxy complex xtrasoft coil (640cx3505 / 30367473) was the first coil chosen; it was reported that the coil could not be advanced nor retracted by the physician.The physician removed the coil and the concomitant microcatheter at the same time.After the coil was removed, inspection was performed, and the coil was observed to be in stretched condition.The physician used another 3.5mm x 5.0cm orbit galaxy complex xtrasoft coil as a replacement and the procedure was successfully completed.There was no report of 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 08/10/2020; the returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that the 3.5mm x 5.0cm orbit galaxy complex xtrasoft coil (640cx3505 / 30367473) was the first coil chosen; it was reported that the coil could not be advanced nor retracted by the physician.The physician removed the coil and the concomitant microcatheter at the same time.After the coil was removed, inspection was performed, and the coil was observed to be in stretched condition.The physician used another 3.5mm x 5.0cm orbit galaxy complex xtrasoft coil as a replacement and the procedure was successfully completed.There was no report of 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 device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 3.5mm x 5.0cm orbit galaxy complex xtrasoft coil was received contained in a pouch.Visual inspection was performed.No damage was noted on the device.A microscopic inspection followed.The embolic coil is still inside the introducer and in good condition.Functional evaluation: a lab sample prowler select plus microcatheter was flushed with a lab sample syringe.After flushing the returned device was introduced into the microcatheter; there was no resistance / friction experienced when the device was advanced through the microcatheter.The device advanced without issue.A review of manufacturing documentation associated with this lot (30367473) 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 the 3.5mm x 5.0cm orbit galaxy complex xtrasoft coil was the first coil used for the procedure, but it could not be advanced nor retracted by the physician.The complaint device was then removed with the concomitant microcatheter, upon inspection after removal, the coil was observed in stretched condition.The reported issues related to advancement / retraction and of the condition of the device being stretched was not confirmed based on the inspection and functional evaluation performed on the returned device.No damage was observed on the coil introducer and the embolic coil.The device was introduced into a lab sample microcatheter and it advanced without any difficulty.Based on the review of the manufacturing documentation, there is no indication that the event is related to the device manufacturing process.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 CMPLX XTRASOFT COIL 3.5X5
• 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: 10353370
• Report Number: 3008114965-2020-00286
• Device Sequence Number: 17010109
• Product Code: KRD
• UDI-Device Identifier: 10886704030683
• UDI-Public: 10886704030683
• 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): 07/12/2020

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: 01/31/2022
• Device Model Number: 640CX3505
• Device Catalogue Number: 640CX3505
• Device Lot Number: 30367473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/12/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1