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

Catalog Number	CDF10030630
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr: a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The device is expected for return but not yet returned.If it is returned the results of investigation will be provided in a supplemental report.
Event or Problem Description
The contact from the facility reported that the deltapaq coil (b)(4) could not be advanced through the excelsior sl-10 microcatheter body and was retrieved by the physician.It was the 4th coil in the procedure.The physician pulled the coil and excelsior sl-10 microcatheter out at the same time.After pulling out the coil it appeared to be stretched.The physician used a similar product to finish the procedure.The procedure was successfully finished.The device did not kink or bend at any time.The concomitant product reportedly bent.An adequate continuous flush was maintained through the catheter.
Additional Manufacturer Narrative
The deltapaq will not be returned, therefore the root cause of the coil unable to be advanced through the microcatheter cannot be determined.Dhr: a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.
Additional Manufacturer Narrative
The device was returned.The sl-10 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.Unreported damage of the device positioning unit (dpu) protruding outside the introducer sheath located 18.0 centimeters off the distal tip of the green introducer was found.No mechanical sheath damage was found at the protrusion site.The coil was returned undamaged with no stretching found.No manufacturing defects were found.Conclusion: the complaint of the coil unable to be advanced through the sl-10 microcatheter cannot be confirmed.Without the return of the microcatheter and due to the coil being returned undamaged, the exact root cause of the coils advancement difficulty and the reason for the microcatheter¿s withdrawal cannot be determined, however a possible contributing factor to the coil¿s advancement difficulty and the microcatheter¿s removal was stated in the complaint as, ¿¿the device did not kink or bend at any time.The concomitant product reportedly bent¿¿ the complaint may have been related to possible microcatheter damage which impeded the coils advancement and may have caused the dpu to protrude outside the introducer sheath, however the exact cause of the coils protrusion outside the introducer sheath cannot be determined (which by itself could produce an advancement difficulty with the coil).The circumstances of how and when the microcatheter was damaged cannot be determined.In addition, without the return of the sl-10 microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.The complaint of the coil appearing to be stretched after removal is not confirmed.The coil was returned undamaged and was found not to be stretched; therefore the root cause of the coil appearing to be stretched cannot be determined.Dhr: a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information and analysis, the event was not confirmed.The returned product passed testing and a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.

• 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: 6119358
• Report Number: 2954740-2016-00277
• Device Sequence Number: 82235
• Product Code: HCG
• UDI-Device Identifier: 00878528007197
• UDI-Public: (01)00878528007197(17)200731(10)C37633
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2016

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: 07/31/2020
• Device Catalogue Number: CDF10030630
• Device Lot Number: C37633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/26/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/21/2016
• Supplement Report FDA Received Date: 12/15/2016; 01/06/2017
• Patient Sequence Number: 1