MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPL CERE COIL 10 SYS 4X8; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CPL10040830
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This initial/final mdr will be the only report submitted for mfr report #3008114965-2018-00668.Additional patient and initial reporter information were requested but could not be provided.(b)(4).Conclusion: the device was received for analysis.The embolic coil is fully advanced out of the introducer.The device is fully unsheathed.The resheathing tool is advanced all the way to the green introducer.There are no apparent kinks or bends in the device positioning unit (dpu) core wire.The embolic coil is kinked.The ball tip is intact.The articulating joint is aligned.The rh coil has not heated.The v-notch of the resheathing tool is undamaged.An attempt was made to resheath the device and retract the embolic coil into the introducer.Because the resheathing tool was advanced all the way to the green introducer, past the end of the skive of the translucent introducer sheath, the device could not be resheathed.Additionally, damage to the embolic coil would prevent advancement of the device.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Nonconformance (b)(4) was generated to evaluate the impact of possible contamination observed in a bottle of neutralizer.The neutralizer was determined to be acceptable for use and all product was released.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint that the device was impeded in the introducer is not confirmed.The returned device was fully advanced out of the introducer.However, observed damage to the embolic coil could prevent the device from advancing.The embolic coil is kinked.No cause for the damage to the embolic coil can be determined based on the condition of the returned device.The device was returned with the embolic coil outside of the protective introducer sheath, so it is possible that some or all of the observed damage occurred after the reported event, when the device was being processed for storage or return.One-hundred percent (100%) of devices are inspected for damage to the embolic coil at final assembly and also at quality control (qc) final inspection.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage.The resheathing tool has been advanced all the way to the green introducer, which has damaged the distal end of the skive of the translucent introducer sheath, preventing the device from being resheathed.The ifu instructs the user to leave approximately 1 inch of the translucent introducer sheath visible when unsheathing the device.This prevents kinking or tearing of the sheath at the distal end of the skive, which would render the device unable to be resheathed.There is no current safety signal identified related to the reported event based on review of complaint history for the device.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
It was reported by a healthcare professional that during an aneurysm embolization procedure, the physician was unable to advance a deltaplush coil (cpl10040830/s11187) in the microcatheter and the physician felt that the device might have been damaged.The physician decided not to put this device in the patient and used another device without any issues.There were no patient consequences or delay in procedure as a result of this event.There was no damage noted to the device prior to the procedure.A sl10 stryker microcatheter was used during the procedure and no kinks or bends were noted to the microcatheter that may have contributed to the reported event.There were no other devices used with the microcatheter prior to the event.An adequate continuous flush was not maintained through the catheter at all times.Note: this event was deemed mdr reportable based on device evaluation results.

• Brand Name: DELTAPL CERE COIL 10 SYS 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: 7672374
• Report Number: 3008114965-2018-00668
• Device Sequence Number: 19059061
• Product Code: HCG
• UDI-Device Identifier: 00878528008316
• UDI-Public: 00878528008316
• Combination Product (Y/N): N
• PMA/510(K) Number: K083646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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: 06/30/2021
• Device Catalogue Number: CPL10040830
• Device Lot Number: S11187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/09/2018
• Patient Sequence Number: 1