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

Catalog Number	CDF10025430
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that product would be returned for analysis; however, the device has not been returned.Additional information will be submitted within 30 days of receipt.This is 1 of 5 mdrs being submitted for this complaint, with associated mdr report numbers of 2954740-2016-00189, 2954740-2016-00190, 2954740-2016-00191, 2954740-2016-00192 and 2954740-2016-00193.
Event or Problem Description
As reported by a healthcare professional, 5 deltapaq coils (cdf10015230/ c37792, cdf10025430/ c36045, cdf10020430/ c36101, cdf10020330/ c40094 and cdf10030630/ c37174) failed to detach.The detachment cable and dcb were changed, but the coils could not be detached.All of the coils were used in the same case, but not used consecutively.There were no potential patient adverse events.It was reported that product would be returned for analysis.
Additional Manufacturer Narrative
It was initially reported that the device would be returned for analysis; however, after multiple attempts, no product was returned and no additional information provided.As reported by a healthcare professional, 5 deltapaq coils (cdf10015230/c37792, cdf10025430/c36045, cdf10020430/c36101, cdf10020330/c40094 and cdf10030630/c37174) failed to detach.The detachment cable and dcb were changed, but the coils could not be detached.All of the coils were used in the same case, but not used consecutively.There were no potential patient adverse events.It was reported that products would be returned for analysis; however, multiple attempts to have the device returned and to obtain additional information were unsuccessful.The devices were not returned for analysis.A review of the manufacturing documentation associated with these lots presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The deltapaq coil failure to detach could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural/handling factors may have contributed to the event.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.This is 1 of 5 mdrs being submitted for this complaint, with associated mdr report numbers of 2954740-2016-00189, 2954740-2016-00190, 2954740-2016-00191, 2954740-2016-00192 and 2954740-2016-00193.
Additional Manufacturer Narrative
The device was returned on 10/4/2016.As reported by a healthcare professional, 5 deltapaq coils (cdf10015230/c37792, cdf10025430/c36045, cdf10020430/c36101, cdf10020330/c40094 and cdf10030630/c37174) failed to detach.The detachment cable and dcb were changed, but the coils could not be detached.All of the coils were used in the same case, but not used consecutively.There were no potential patient adverse events.It was reported that products would be returned for analysis; however, multiple attempts to have the device returned and to obtain additional information were unsuccessful.Deltapaq lot c36045 was returned for analysis.The unidentified detachment control box (dcb) and the 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.Unreported damage of the complete introducer sheath with the resheathing tool was not being returned was found.The coil was returned undamaged.The detachment fiber was intact, undamaged, and did not receive heat and melt.The device positioning unit (dpu) passed electrical testing with resistance at 52.4 ohms (range 48.5/56.0) and the enpower 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 52.5 ohms.The field complaint of the coils non-detachment could not be duplicated.Post-detachment inspection found that the detachment fiber received heat and melted as designed.No manufacturing defects were found.The circumstances of how and when the introducer sheath with the resheathing tool was removed from the dpu and coil and not returned cannot be determined.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 coils non-detachment was not confirmed.The dpu passed electrical testing and the coil 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, the complete introducer sheath with the resheathing tool, 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 of a manufacturing issue related to the event, no corrective actions will be taken at this time.This is 1 of 5 mdrs being submitted for this complaint, with associated mdr report numbers of 2954740-2016-00189, 2954740-2016-00190, 2954740-2016-00191, 2954740-2016-00192 and 2954740-2016-00193.

• 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: 5910142
• Report Number: 2954740-2016-00190
• Device Sequence Number: 493414
• Product Code: HCG
• UDI-Device Identifier: 00878528007135
• UDI-Public: (01)00878528007135(17)200531(10)C36045
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup
• Report Date (Section B): 08/16/2016

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: 05/31/2020
• Device Catalogue Number: CDF10025430
• Device Lot Number: C36045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/16/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/29/2016
• Supplement Report FDA Received Date: 09/27/2016; 10/11/2016
• Patient Sequence Number: 1