MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDF10021030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is two of two initial/final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00227 and 2954740-2016-00226 this report being submitted for coil a.Concomitant medical products: micro catheter (excelsior 1018, boston scientific); enpower; deltamaxx coils (lot unknown); competitor's coils (lot unknown).The excelsior 1018 microcatheter and the rotating hemostatic valve (rhv) were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned before being returned which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location and measurement callouts are approximate and for reference only.The two microcoil systems with the same lot number (c41365) were returned unidentified as to which product investigation (pi) as one unit was resistance and the other was resistance and the ¿coil split¿ which lacks any clarification.Both coils were returned unsheathed.Due to improper handling, cleaning, and packaging, it cannot be determined if this unreported damage occurred during the procedure to both return coils.Due to the lack of identification and clarification as to which complaint the coils belong to, the coils will be identified as coil ¿a¿ and coil ¿b.This report being submitted for coil a.Concerning coil ¿a¿: as viewed through the returned packaging, unreported damage of the device positioning unit (dpu) was returned without the coil attached.Unreported damage of the dpu and the introducer sheath were found returned completely separated from each other.Unreported damage of the stretched resistance suture protruding out of the sheath 70.5 centimeters off the distal tip of the green introducer.The unintended coil detachment was mechanical in nature.The undamaged and detached coil was found at the protrusion site.No manufacturing defects were found.Due to the severe damage, the non-return of the microcatheter, and due to the coil separation, the field complaint could not be duplicated.The circumstances of how and when all the unreported damage occurred to coil ¿a¿ cannot be determined.Concerning coil ¿a¿, the complaint of the resistance inside the microcatheter is not confirmed.Due to the unreported condition of the coil being returned detached and without the return of the microcatheter, the root cause of the coils resistance inside the microcatheter cannot be determined.In addition without the return of the excelsior 1018 microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.The complaint of the coil splitting is confirmed.Due to the unreported condition of the coil being returned detached and without the return of the microcatheter, and a complete lack of clarification in the event description, the root cause of the coil splitting during insertion with force by the end user cannot be determined.In addition without the return of the excelsior 1018 microcatheter and the rhv used in the procedure, it cannot be determined if this component contributed to the complaint event.Complaint of ¿coil splitting¿ was confirmed with coil a; however the root cause of the complaint could not be determined.The complaint of the resistance experienced with coil a was not confirmed.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.A review of the manufacturing documentation associated with this lot c41365 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.
Event or Problem Description
As reported by a health care professional, resistance was experienced with the microcatheter when 2of deltamaxx coils (cdx18031230/c41165, cdx18206030/c38424) and 2 of c-deltapaq coils (cdf10021030/c41365) were being used.The procedure was coil embolization of an aneurysm at the superficial femoral artery.The patient's gender and age were unknown.The patient's vessel were not torturous and not calcified.A contralateral approach was made with a guiding catheter (type lot unknown) and micro catheter (competitor's device).After insertion of several deltamaxx coils, the c-deltapaq (c41365) was inserted into the micro catheter.However there was strong resistance felt at the middle of the micro catheter.Therefore, the coil was replaced with another coil (same size, lot# c41365); however the same issue occurred with this coil.The coil split when the physician tried inserting the coil with force; the coil was retrieved and was replaced with a deltamaxx (lot unknown).After placing several deltamaxx, a deltamaxx cere 3mm (lot# c41165) was inserted; however there was strong resistance and the coil was retrieved.A competitor's coil was used instead and placed in the lesion.Following placement of several coils, a deltamaxx 20mm (c38424) was inserted.However, there was resistance and the coil was oversized for the aneurysm, therefore it was retrieved.Finally a deltamaxx 18mm (lot unknown) and 17 of competitor's coils were used in the procedure.The procedure was successfully completed without further issues or delay.There were no patient injuries or complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush had been maintained at all time.No visible defect or 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 but one of deltamaxx (cdx18206030/c38424) has already been disposed and not available for the investigation.No further information is available.

• Brand Name: DELTAPAQ - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 5997547
• Report Number: 2954740-2016-00227
• Device Sequence Number: 912079
• Product Code: HCG
• UDI-Device Identifier: 00878528007111
• UDI-Public: (01)00878528007111(17)210228(10)C41365
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K080437
• 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): 08/31/2016

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: 02/28/2021
• Device Catalogue Number: CDF10021030
• Device Lot Number: C41365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 10/04/2016
• Patient Sequence Number: 1