MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 3MM X 5.4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100305
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted to being stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter email address: (b)(6).Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(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 the prepping of a 3mm x 5.4cm micrusframe10 coil (mfr100305, l14989), the sheath split.There was no patient injury reported.The procedure was completed by a competitor¿s coil.The product was stored according to labeling instructions.The device was adequately used.There was no excessive force applied at any time during the procedure.The coil device was attempted to be inserted into the sl10 microcatheter (mc).There was no resistance/friction encountered when inserting the coil delivery system into the microcatheter.There were no kinks on the mc that may have contributed to the event.There was no evidence of damage to the actual coil (i.E.Stretching, kinked, detached, separated).A non-sterile unit micrusframe10 3mm x 5.4cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found kinked at 186, 188 and 189 cm and protruded from introducer.Also, the marker band was found at 40 cm from distal end, and it was found within specification.The re-sheathing tool was inspected, and it was found in good normal conditions.The introducer was inspected, and it was found unzipped and kinked.The v-notch was inspected under microscope and it was found in good normal conditions.The rh and the articulation joint were inspected under microscope and they were found in good normal conditions.As well as the rh was no heated.The embolic coil was inspected under microscope and it was found stretched.A manufacturing record evaluation was performed for the finished device l14989 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil introducer - premature peeling¿ was confirmed, during the visual inspection.It was noted that the dpu protruded from introducer.The kinked condition noted on the dpu and introducer could be related with the complaint reported by the costumer and may have be appearing to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Neither the product analysis nor the mre review suggests that the failure could be related to the manufacturing process.The instructions for use (ifu) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing the embolic coil into the microcatheter, there is a risk that the embolic coil will be unsheathed and pass through the resheathing tool.This can cause damage to the embolic coil and can also cause it to protrude from the introducer.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.
Event or Problem Description
As reported by a healthcare professional, during the prepping of a 3mm x 5.4cm micrusframe10 coil (mfr100305, l14989), the sheath split.There was no patient injury reported.The procedure was completed by a competitor¿s coil.The product was stored according to labeling instructions.The device was adequately used.There was no excessive force applied at any time during the procedure.The coil device was attempted to be inserted into the sl10 microcatheter (mc).There was no resistance/friction encountered when inserting the coil delivery system into the microcatheter.There were no kinks on the mc that may have contributed to the event.There was no evidence of damage to the actual coil (i.E.Stretching, kinked, detached, separated).Based on the analysis of the device received, the embolic coil was stretched.

• Brand Name: MICRUSFRAME10 3MM X 5.4CM
• 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: 8865393
• Report Number: 3008114965-2019-01112
• Device Sequence Number: 2587036
• Product Code: KRD
• UDI-Device Identifier: 10886704077800
• UDI-Public: 10886704077800
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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 Catalogue Number: MFR100305
• Device Lot Number: L14989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1