MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 6X20; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0620
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg 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.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, during a coil embolization, a 6x20 og tdl cmplx fill coil (640cf0620, 30359244) was being used as the first coil.The coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the microcatheter at the same time.After inspection, it turns out that the coil was stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.No additional information is available.
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 the field, during a coil embolization, a 6x20 og tdl cmplx fill coil (640cf0620, 30359244) was being used as the first coil.The coil couldn't be advanced nor retrieved by the physician.The physician pulled the coil and the microcatheter at the same time.After inspection, it turns out that the coil was stretched.The physician used a same like product.The procedure was successfully finished.There was no patient injury reported.No additional information is available.One non-sterile og tdl cmplx fill coil 6x20 was received inside of a pouch.The received device was visually inspected, and the hypo-tube was found broken in two.Then a microscopic inspection was performed, and no other damages could be observed.The embolic coil was found in good conditions outside from the introducer.The functional analysis could not be performed due the conditions of the received device (hypo-tube broken) a manufacturing record evaluation was performed for the finished device 30359244 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿detachable coil delivery system (dcs)- impeded in microcatheter with no loss of cerebral target position¿ was not able to confirmed, the hypo-tube was found broken and the functional test could not be performed.The complaint reported by the customer ¿coil - unraveled/stretched-in microcatheter¿ was not confirmed since no damages were noted on the embolic coil.Neither the analysis or the mre suggest that the failure reported could be related to the manufacturing process.The instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.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.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 TDL CMPLX FILL COIL 6X20
• 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: 10275831
• Report Number: 3008114965-2020-00287
• Device Sequence Number: 811841
• Product Code: KRD
• UDI-Device Identifier: 10886704030348
• UDI-Public: 10886704030348
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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: 640CF0620
• Device Catalogue Number: 640CF0620
• Device Lot Number: 30359244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED MICROCATHETER.