MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X8; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0408
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2020
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.(b)(4).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.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
Hold for jordan 4.22 as reported by a healthcare professional, during a coil embolization, a 4x8 og cmplx xtrasoft coil (640cx0408, 30250554) failed to recapture.The doctor used a same kind of product and the procedure was successfully finished.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint # (b)(4) 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 a healthcare professional, during a coil embolization, a 4x8 og cmplx xtrasoft coil (640cx0408, 30250554) failed to recapture.The doctor used a same kind of product and the procedure was successfully finished.There was no patient injury reported.One non-sterile unit og cmplx xtrasoft coil 4x8 was received inside of a pouch.The received device was visually inspected, no damages were noted on it.Then a microscopic inspection was performed, the embolic coil was found kinked, no other damages were observed.The functional analysis could not be performed due the kinked condition noted on the embolic coil.A manufacturing record evaluation was performed for the finished device 30250554 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - withdrawal difficulty-into microcatheter¿ was confirmed.Although the functional analysis could not be performed the embolic coil was found kinked and this condition may have contributed to the failure reported by the customer.The kinked condition noted on the embolic coil appears to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the device history record review nor the product analysis suggest that the reported failure could be related to the manufacturing process of the unit.Withdrawal difficulty is a known potential issues associated with the use of the device.The instructions for use (ifu) contains instructions and cautions regarding proper placement of the device, including introduction and positioning of the microcoil.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.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: OG CMPLX XTRASOFT COIL 4X8
• 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: 9985568
• Report Number: 3008114965-2020-00124
• Device Sequence Number: 3896367
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: 10886704030638
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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: 05/31/2021
• Device Model Number: 640CX0408
• Device Catalogue Number: 640CX0408
• Device Lot Number: 30250554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1