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

Catalog Number	CDF10020430
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 mdr's 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 c36101 was returned for analysis.The sheath was severed and not returned.The complete introducer sheath was not returned.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 71.0 centimeters of the sheath¿s length was found to have been severed and not returned.The coil was returned undamaged.The coil¿s stretch resistant suture was captured by the partially melted detachment fiber.The device positioning unit (dpu) passed electrical testing with resistance at 53.5 ohms (range 48.5/56.0) and the enpower and cable systems ready green light illuminated.No manufacturing defects were found.The circumstances of how and when the unreported damage of the sheath being severed cannot be determined.A review of the manufacturing documentation associated with this lot c36101 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.; the coil non-detachment was confirmed.The dpu passed electrical testing, however the detachment fiber partially melted and captured the coil¿s stretch resistant suture and remained attached to the dpu.While the exact root cause cannot be determined, the most likely contributing factor to the partially melted detachment fiber that captured the coil¿s stretch resistance suture may have been to a loss of fiber tension that may have caused the detachment fiber to lose contact with the heating surface on one side causing a partially melting of the fiber.The circumstances that may have produced the partially fiber melting cannot be determined as the unidentified microcatheter and the complete, but unidentified detachment system were not returned.In addition, without the identification or the return of the unknown microcatheter and the unspecified detachment system 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: 5910150
• Report Number: 2954740-2016-00191
• Device Sequence Number: 330253
• Product Code: HCG
• UDI-Device Identifier: 00878528007081
• UDI-Public: (01)00878528007081(17)200531(10)C36101
• 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: CDF10020430
• Device Lot Number: C36101
• 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