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

Model Number	640CX3575
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not 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.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, a 3.5x7.5 og cmplx xtrasoft coil (640cx3575, 30284964) was being used as the first coil.When the physician tried to detach the coil, the beeping sound was normal but during retrieving delivery system, it continuously came out along the delivery system.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this report: d10, g4, g7, h2, h3, h6 and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, a 3.5x7.5 og cmplx xtrasoft coil (640cx3575, 30284964) was being used as the first coil.When the physician tried to detach the coil, the beeping sound was normal but during retrieving delivery system, it continuously came out along the delivery system.There was no patient injury reported.One non-sterile og cmplx xtrasoft coil 3.5x7.5 was received inside of a pouch.The received device was visually inspected, and the hypo-tube was found kinked at 98.3cm and 120.5cm.The gripper was found with a curvy condition partially outside of the introducer.Then a microscopic inspection was performed, and the gripper could be noted kinked and with some residues of saline solution.No other damages could be observed.A functional test was not able to be performed due to returned conditions; however according to the ifu of the device a trufill® dcs syringe ii is required to properly purge and detach the coil.The coil is detached from the delivery tube by a proprietary hydraulic release mechanism.A manufacturing record evaluation was performed for the finished device 30284964 number, and no non-conformances related to the reported complaint condition were identified the complaint reported by the customer ¿coil - failure to detach¿ was not able to confirm as the functional analysis could not be performed due the conditions of the received device.The damaged condition noted on the device may have appeared to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis or the mre suggest that the failure reported could be related to the manufacturing process.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.

• 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: 10108436
• Report Number: 3008114965-2020-00214
• Device Sequence Number: 16996117
• Product Code: KRD
• UDI-Device Identifier: 10886704030706
• UDI-Public: 10886704030706
• Combination Product (Y/N): N
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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: 07/31/2021
• Device Model Number: 640CX3575
• Device Catalogue Number: 640CX3575
• Device Lot Number: 30284964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1