MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 2MMX10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CDF100210-30
Medical Device Problem Codes	Material Twisted/Bent (2981); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Initial reporter phone: (b)(6).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 (l10870) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances 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 stent-assisted aneurysm embolization procedure targeting a left posterior communicating artery (pcomm) aneurysm, the 2mm x 10cm deltapaq 10 cerecyte coil (cdf10021030 / l10870) unexpectedly become detached when the coil was in the introducer before crossing the microcatheter.Another 2mm x 10cm deltapaq 10 cerecyte coil was used to complete the procedure.The reported issue did not cause a procedural delay.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the returned complaint device on 09/01/2020; the returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that during the stent-assisted aneurysm embolization procedure targeting a left posterior communicating artery (pcom) aneurysm, the 2mm x 10cm deltapaq 10 cerecyte coil (cdf10021030 / l10870) unexpectedly become detached when the coil was in the introducer before crossing the microcatheter.Another 2mm x 10cm deltapaq 10 cerecyte coil was used to complete the procedure.The reported issue did not cause a procedural delay.There was no report of any patient adverse event or complication.The product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 2mm x 10cm deltapaq 10 cerecyte coil was received contained in a pouch.Visual inspection was performed.The device positioning unit (dpu) was observed kinked at 120cm from the proximal end.The dpu was also protruding from the introducer.No other damages or anomalies were observed during the visual inspection.The device underwent a microscopic inspection.Under magnification, the embolic coil was observed mechanically detached in kinked / damaged condition.The resistance heating (rh) coil did not show evidence that it had been heated.A review of manufacturing documentation associated with this lot (l10870) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint documented that during the stent-assisted embolization procedure, the 2mm x 10cm deltapaq 10 cerecyte coil unexpectedly detached when the coil was in the introducer before crossing the concomitant microcatheter.The reported issue was confirmed based on the microscopic inspection where it was observed that the embolic coil is detached and kinked while the rh coil did not show sign of being heated that is indicative of an initiated detachment cycle.The exact cause of the premature detachment of the embolic coil cannot be conclusively determined, however, it is likely the result of applied force during procedural handling.The dpu was kinked and protruding from the introducer suggest that force may have inadvertently been applied.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 2mm x 10cm deltapaq 10 cerecyte coil left the manufacturing facility with the embolic coil detached, the dpu kinked and protruding from the coil introducer as observed on the returned device.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 CERE 2MMX10CM
• 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: 10473456
• Report Number: 3008114965-2020-00350
• Device Sequence Number: 2939629
• Product Code: HCG
• UDI-Device Identifier: 00878528007111
• UDI-Public: 00878528007111
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: 10/31/2022
• Device Model Number: CDF100210-30
• Device Catalogue Number: CDF10021030
• Device Lot Number: L10870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR