MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 1.5MMX2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDF10015230
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient age/date of birth, gender, weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Physical manufacturer name: codman and shurtleff inc, dba depuy synthes products, inc.(b)(4).The product lot number was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail, was not reported.It was not reported if the product is available for evaluation and testing and it has not been received to date.Additional information will be submitted within 30 days of receipt.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
A report from the field indicated that the green ¿system ready¿ light did not illuminate when the 1.5 mm x 2 cm deltapaq (cdf10015230/unk lot) coil was connected to the enpower detachment control box (dcb).There was no report of consequence or impact to the patient.It was not reported if the product will be returned for evaluation.No further information was provided.
Additional Manufacturer Narrative
(b)(4).Complaint conclusion: a report from the field indicated that the green ¿system ready¿ light did not illuminate when the 1.5mm x 2cm deltapaq (cdf10015230/unk lot) coil was connected to the enpower detachment control box (dcb).There was no report of consequence or impact to the patient.Multiple attempts to obtain additional information were unsuccessful.A non-sterile 1.5mm x 2cm deltapaq was received inside of a pouch.Visual inspection was performed on the returned device.The device positioning unit (dpu) and hub connector were undamaged.The resheathing tool was undamaged.The introducer was found zipped and undamaged.The device was then examined under a microscope.The v-notch of the resheathing tool was seen undamaged.The articulating joint was seen present and intact.No damage was noted to the embolic coil.The distal outer sheath was not softened, indicating that the resistance heating coil had not been heated and the detachment process had not been initiated.The resistance of the device was measured with multimeter and found within specification.The device was then connected to a lab sample enpower detachment control box (b)(4) (dcb) with a lab sample enpower control cable and the power was turned on.The ¿system ready¿ light illuminated.The embolic coil was immersed in warmed enzyme solution and the ¿detach¿ button was pressed.The embolic coil detached.The manufacturing record evaluation (mre) cannot be performed since the lot number was not provided.The customer report of failure to detach was not confirmed during functional testing.The embolic coil detached successfully under laboratory conditions.The device was returned with no signs of the detachment process being initiated since the distal outer sheath had not been softened and the embolic coil was still attached.The control cable and dcb used during the reported event were not returned.Without the return of these devices, the cause of the reported event cannot be determined.The device does not present any obvious indication of manufacturing defect or anomaly that could have contributed to the event as reported.Failure to detach is a known potential product failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that procedural and handling factors may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report that the product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: DELTAPAQ CERE 1.5MMX2CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CA CH-24 00; SZ CH-2400
• MDR Report Key: 8470349
• Report Number: 3008114965-2019-00976
• Device Sequence Number: 19313136
• Product Code: HCG
• UDI-Device Identifier: 00878528007012
• UDI-Public: 00878528007012
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2019

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 Catalogue Number: CDF10015230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 05/06/2019; 06/06/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/13/2019; 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENPOWER DCB