MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME COIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100626
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device met mdr reporting criteria on 12/16/2017 when it was determined during product analysis that the coil was kinked.Customer information could not be provided.The name and email in initial reporter is for the (b)(6) affiliate.Procode: krd/hcg.(b)(4).Conclusion: as reported by a healthcare professional, during coil embolization of an anterior communicating artery aneurysm, two micrus frame 10 coils (mfr100626/s13305) could not pass through the headway microcatheter.The micrusframe coils were inserted in the microcatheter; however, the microcoils did not come out from the distal tip of the microcatheter.Therefore, they were removed from the patient and it was later confirmed that the microcoil did not come out from the distal tip of the microcatheter outside the patient either.The microcatheter did not appear damaged and the devices were prepped and used as per the ifu.It was unknown how the procedure was completed; however, the procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the microcatheter.No further information is available.The device was returned fully sheathed.The distal end of the embolic coil is located in the middle of the green introducer.There is a slight bend in the dpu core wire approximately 27 cm from the proximal end.The ball tip is intact.The embolic coil is kinked.The articulating joint is misaligned.The condition of the rh coil is obscured by the translucent introducer sheath.Advancement of the embolic coil out of the introducer was attempted.The embolic coil could not be advanced out of the introducer because of friction from the misaligned embolic coil.Since the embolic coil cannot be advanced out of the introducer, advancement through a microcatheter cannot be attempted.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the device is impeded was confirmed.The embolic coil was kinked and the articulating joint was misaligned.The coil could not advance through the introducer because of the damage to the articulating joint.When manufactured, the two components of the articulating joint are aligned.Pressure from the dpu side of the joint is translated into motion of the embolic coil straight through the introducer.In the case of device b, the embolic coil is slightly offset and angled away from the joint.Pressure from the dpu side of the joint is translated into motion of the embolic coil towards and against the wall of the introducer, creating friction and impeding progress.One-hundred percent (100%) of devices are inspected in-process for the ability to advance through the introducer and retract back.Damage to the articulating joint sufficient to prevent advancement of the embolic coil would be observed at this inspection.In addition, 100% of devices are inspected for damage to the embolic coil, including kinks.Thus, it is unlikely that the observed issues were present when the device left the manufacturing facility.The slight bends in the dpu core wires for both devices suggests that excessive force was applied to each device, which may have resulted in the damage to the articulating joints on both devices and the kink that was observed.There is no current safety signal identified related to the reported event based on review of complaint history for the device.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of an anterior communicating artery aneurysm, two micrusframe10 coils ( mfr100626/s13305) could not pass through the headway microcatheter, and during product analysis, it was discovered that one of the coils was kinked.The micrusframe coils were inserted in the microcatheter; however, the microcoils did not come out from the distal tip of the microcatheter.Therefore, they were removed from the patient and it was later confirmed that the microcoil did not come out from the distal tip of the microcatheter outside the patient either.The microcatheter did not appear damaged and the devices were prepped and used as per the ifu.It was unknown how the procedure was completed; however, the procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the microcatheter.The products will be returned for the investigation.No further information is available.

• Brand Name: MICRUSFRAME COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 7138198
• Report Number: 3013875781-2017-00047
• Device Sequence Number: 1211272
• Product Code: HCG
• UDI-Device Identifier: 10886704077862
• UDI-Public: (01)10886704077862(17)200131(10)S13305
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2017

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: 01/31/2020
• Device Catalogue Number: MFR100626
• Device Lot Number: S13305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2017
• Initial Report FDA Received Date: 12/21/2017
• Patient Sequence Number: 1
• Patient Age: 64 YR