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

Model Number	640CX3575
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
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 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 (30334351) 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 / 30334351) was chosen as the framing coil, but the coil could not be advanced nor retrieved by the physician.The physician pulled the coil and the microcatheter at the same time from the patient.Inspection after removal it was observed that the coil was stretched.The physician used 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 or complication.
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 07/30/2020.The returned product underwent evaluation and analysis.This mdr submission also include a correction to the device expiration date.[conclusion]: the healthcare professional reported that the 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil (640cx3575 / 30334351) was chosen as the framing coil, but the coil could not be advanced nor retrieved by the physician.The physician pulled the coil and the microcatheter at the same time from the patient.Inspection after removal it was observed that the coil was stretched.The physician used 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 or complication.Multiple attempts were made to obtain additional information related to the procedure and the reported device were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil was received contained in a pouch.Visual inspection was performed.Visual inspection was performed the hypotube was observed kinked at 106.5cm and 123cm from the proximal end.The returned device underwent a microscopic inspection.The embolic coil was observed in good condition outside of the coil introducer.No damage was observed under the microscopic magnification.Functional evaluation was precluded due to the condition of the hypotube; there were kinked areas at 106.5cm and 123cm from the proximal end.A review of manufacturing documentation associated with this lot (30334351) 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 7.5cm orbit galaxy complex xtrasoft coil could not be advanced nor retrieved, the reported issue is likely due to the kinked areas noted on the hypotube of the returned device; this observation confirmed the issue that the coil could not be advanced nor retrieved.It was reported that after removal from the patient, the coil was observed stretched.This issue was not confirmed based on the microscopic inspection performed on the returned device.The embolic coil was observed outside of the coil introducer but was in good condition with no appearance of damage.The cause of the kinked hypotube cannot be conclusively determined; however, it is likely due to undue force that may have inadvertently been applied during procedural handling.The physician reported that the coil could not be advanced nor retrieved, it is possible that during the attempt to advance / retrieve the coil, force was applied which resulted in the two kinked areas noted on the hypotube.Based on the manufacturing documentation review, 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 hypotube component in kinked condition as noted 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.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: 10303116
• Report Number: 3008114965-2020-00261
• Device Sequence Number: 11476376
• 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): 07/01/2020

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: 640CX3575
• Device Catalogue Number: 640CX3575
• Device Lot Number: 30334351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1