MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPL CERE COIL 10 SYS 1.5X2; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CPL10015230
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The phone and email address of the initial reporter are not available / reported.Physical manufacturer name: (b)(4) the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (s13546) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the coil embolization, the 1.5mm x 2cm deltaplush 10 cerecyte coil (cpl10015230 / s13546) could not be detached.The coil was withdrawn, and another coil was used to complete the procedure.There was no report of patient injury or complication.It was reported that the product is available to be returned for evaluation and analysis.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the coil embolization, the 1.5mm x 2cm deltaplush 10 cerecyte coil (cpl10015230 / s13546) could not be detached.The coil was withdrawn and was successfully removed from the patient still attached to the delivery system and was not in a stretched condition; another coil was used to complete the procedure.It was reported that the enpower detachment control box and enpower connecting cable were used and the same detachment control box and connecting cable were used to detach subsequent coils.A pre-deployment electrical check was performed; the fault light was not seen and upon pressing the power button, all lights illuminated and then the green system ready light illuminated.The detachment light illuminated, and the audible signal beep was heard.There was no report of patient injury or complication; the event did not result in any clinically significant delay.The product was returned for evaluation.The investigational finding is documented below.Investigation summary: the non-sterile 1.5mm x 2cm deltaplush 10 cerecyte coil was received contained in a pouch.Visual inspection was performed.The device and its components appeared in normal condition without any damage.The v-notch, resheathing tool, resistance heating (rh), and the embolic coil were all in normal condition without any damage.The rh did not show evidence of being heated.Functional test was performed.The coil showed resistance when it was connected to the enpower control cable and connected to the multimeter; the reason was 52.6 , this is within the specification range of 48.5 - 56.0.The coil has electrical continuity.The device was connected to the enpower control cable and then connected to the detachment control box (dcb) and the power was turned on.The green system ready light illuminated, and the detachment button was pressed to initiate detachment.The coil was detached.The reported issue that the coil could not be detached during the procedure was not confirmed with functional analysis performed on returned device.A review of manufacturing documentation associated with this lot (s13546) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue that the 1.5mm x 2cm deltaplush 10 cerecyte coil could not be detached during the coil embolization procedure was not confirmed.The device was returned without any damage.Functional test was performed, and the coil detached without any issue.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 7/24/2019, and to report that the product was received by the product analysis lab on 7/25/2019.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.[additional information]: the healthcare professional reported that during the coil embolization, the 1.5mm x 2cm deltaplush 10 cerecyte coil (cpl10015230 / s13546) could not be detached.The coil was withdrawn and was successfully removed from the patient still attached to the delivery system and was not in a stretched condition; another coil was used to complete the procedure.It was reported that the enpower detachment control box and enpower connecting cable were used and the same detachment control box and connecting cable were used to detach subsequent coils.A pre-deployment electrical check was performed; the fault light was not seen and upon pressing the power button, all lights illuminated and then the green system ready light illuminated.The detachment light illuminated, and the audible signal beep was heard.There was no report of patient injury or complication; the event did not result in any clinically significant delay.The product was returned for and is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: DELTAPL CERE COIL 10 SYS 1.5X2
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8812559
• Report Number: 3008114965-2019-01071
• Device Sequence Number: 11451285
• Product Code: HCG
• UDI-Device Identifier: 00878528008170
• UDI-Public: 00878528008170
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2019

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 Expiration Date: 02/28/2022
• Device Catalogue Number: CPL10015230
• Device Lot Number: S13546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/24/2019; 07/29/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 07/25/2019; 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1