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

Catalog Number CDF10015430

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during the aneurysm embolization procedure, the deltapaq coil (cdf10015430/s10965) could not be detached.They used another one to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.

Manufacturer Narrative

It was reported that the device would be returned for analysis; however, the device was not returned and after multiple attempts, no additional information was provided.The (b)(4) product was not returned for investigation.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The coil failure to detach could not be confirmed without product return for analysis.The root cause of the event could not be determined.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the events was related to a manufacturing issues, no corrective actions will be taken at this time.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure of an aneurysm, the deltapaq 10 cerecyte coil 1.5mm x 4cm (cdf10015430 / s10965) could not be detached.They used another one to complete the procedure.There was no report of patient injury.Investigation summary: labeling on the inner pouch matches the product documented in the complaint.The introducer was not returned.The embolic coil was detached and not returned with the product.Two bends were observed in the device positioning unit (dpu) core wire approximately at 11 cm and 26 cm from the proximal end.The distal outer sheath has not softened indicating that the resistance heating (rh) coil has not heated.The resistance of the device was measured using multimeter 70042-04d.Resistance measured 51.9.The result is within the specification range of 48.5-56.0 per pic-cspec51460 rev.12.The device was connected to detachment control box dcb000005-00 (dcb) c38341 with a lab connecting cable and power was turned on.The system ready light turned on.Detachment cannot be tested because embolic coil was not returned.A review of manufacturing documentation associated with this lot (s10965) 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.Investigation conclusion: the complaint of failure to detach cannot be confirmed.As returned, the embolic coil is not attached to the dpu.The condition of the rh coil indicates that the detachment was mechanical.The resistance of the returned dpu is within the specification range, and the system ready light illuminates when the dpu is connected to a dcb.This evidence suggests that a detachment cycle was not initiated.The connecting cable and dcb were not returned.Without the return of these devices, the cause of the reported event cannot be identified.Device history lot
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> a review of manufacturing documentation associated with this lot (s10965) 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.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.

• Brand Name: DELTAPAQ - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6886513
• MDR Text Key: 89309795
• Report Number: 2954740-2017-00276
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007036
• UDI-Public: (01)00878528007036(17)210531(10)S10965
• Combination Product (y/n): N
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CDF10015430
• Device Lot Number: S10965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 10/23/2017; 06/28/2018
• Supplement Dates FDA Received: 10/25/2017; 07/18/2018
• Patient Sequence Number: 1