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

Catalog Number	CDF10030830
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It was reported that the device would be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during coil embolization, the deltapaq coil (cdf10030830/ c27888) could not be detached.They successfully withdrew the coil and used a new coil to complete the procedure.There was no report of patient injury or clinically significant delay in the procedure.The coil was not stretched when it was removed and was still attached to the delivery system.An unspecified enpower cable and dcb were used for the procedure, and the same cable and dcb were used to successfully detach the subsequent coils.A pre-deployment electrical check had been performed.The green system ready light illuminated.All connections appeared to fit properly without application of excessive force.It was unknown if during the detachment cycle the detachment light illuminated or the audible signal beeped.Information regarding the target vessel and patient information could not be obtained.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during coil embolization, the deltapaq coil (cdf10030830/ c27888) could not be detached.They successfully withdrew the coil and used a new coil to complete the procedure.There was no report of patient injury or clinically significant delay in the procedure.The coil was not stretched when it was removed and was still attached to the delivery system.An unspecified enpower cable and dcb were used for the procedure, and the same cable and dcb were used to successfully detach the subsequent coils.A pre-deployment electrical check had been performed.The green system ready light illuminated.All connections appeared to fit properly without application of excessive force.It was unknown if during the detachment cycle the detachment light illuminated or the audible signal beeped.Information regarding the target vessel and patient information could not be obtained.It was reported that the device would be returned for analysis.The device was returned for analysis.The unspecified enpower detachment control box (dcb) and the unspecified connecting cable were not returned.The unidentified microcatheter was 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.As viewed through the returned packaging, unreported damage of the device positioning unit (dpu) and the coil were completely separated from the introducer sheath.The circumstances of how and when this removal of the dpu/coil from the introducer sheath occurred cannot be determined.The detachment fiber did not receive heat and melt.The device positioning unit (dpu) passed electrical testing with resistance at 50.2 ohms (range 48.5/56.0) and the lab sample enpower dcb and cable systems ready green light illuminated.The coil detached on the first detachment cycle.Post-detachment inspection found that the enpower systems ready green light remained illuminated and the resistance passed at 50.3 ohms.Post-detachment inspection found that the detachment fiber received heat and melted as designed.The field complaint of the coils non-detachment could not be duplicated.No manufacturing defects were found.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 complaint of the coils non-detachment cannot be confirmed.The dpu passed electrical testing and the coil was detached on the first detachment cycle, therefore the root cause of the coils non-detachment cannot be determined.In addition, without the return of the complete detachment system and the unidentified microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.Since there was no evidence to suggest the event was related to a manufacturing issue, 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: 6043363
• Report Number: 2954740-2016-00248
• Device Sequence Number: 348459
• Product Code: HCG
• UDI-Device Identifier: 00878528007203
• UDI-Public: (01)00878528007203(17)190616(10)C27888
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 09/26/2016

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: 06/16/2019
• Device Catalogue Number: CDF10030830
• Device Lot Number: C27888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2016
• Supplement Report FDA Received Date: 11/08/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED ENPOWER CABLE AND DCB