MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 CERE 5MMX17CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	PC4100517-30
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.(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 (s14305) 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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 coil embolization procedure, it was reported that the 5mm x 17cm presidio 10 cerecyte coil (b)(4) / s14305) failed to be detached.The physician replaced the detachment control box, but the issue still persisted.The physician withdrew the coil from the patient¿s body and replaced with another 5mm x 17cm presidio 10 cerecyte coil to complete the procedure.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 was received by the lab on 07/02/2020; the returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported that during the stent-assisted coil embolization procedure, it was reported that the 5mm x 17cm presidio 10 cerecyte coil (pc410051730 / s14305) failed to be detached.The physician replaced the detachment control box, but the issue still persisted.The physician withdrew the coil from the patient¿s body and replaced with another 5mm x 17cm presidio 10 cerecyte coil to complete the procedure.There was no report of any patient adverse event or complication.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 5mm x 17cm presidio 10 cerecyte coil was received contained in a pouch.Visual inspection was performed.No damage was observed during the visual inspection.A microscopic inspection was performed.The distal outer sheath had not softened, an indication that the resistance heating (rh) coil has not been heated and the detachment process has not been initiated.No other damage was observed during the microscopic inspection.Functional evaluation: the resistance of the device was measured using a multimeter and a lab sample enpower control cable.The resistance was measured to be 53.1 o, which is within the specification range of 48.5 o ¿ 56.0 o.The 5mm x 17cm presidio 10 cerecyte coil was connected to the enpower control cable and the unit was then connected to a detachment control box (dcb).The power was turned on; the green system ready light illuminated, and a detachment cycle was initiated when the detach button was pressed.The embolic coil detached without issue.A review of manufacturing documentation associated with this lot (s14305) 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 complaint documented that the 5mm x 17cm presidio 10 cerecyte coil failed to detach during the procedure even after the physician replaced the detachment control box.The issue was not confirmed through functional evaluation performed on the returned device.The resistance of device was measured and found to be within specification.Using a lab sample enpower control cable and dcb, the coil was detached without issue.The complaint documented that the physician only replaced the dcb in the attempt to troubleshoot the issue of detachment; it is possible that the issue was with the control cable that was used during the procedure.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that the issue was not related to the 5mm x 17cm presidio 10 cerecyte coil but to the control cable.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: PRESIDIO 10 CERE 5MMX17CM
• 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: 10186788
• Report Number: 3008114965-2020-00229
• Device Sequence Number: 886327
• Product Code: HCG
• UDI-Device Identifier: 00878528003014
• UDI-Public: 00878528003014
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002056
• 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): 06/05/2020

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: 05/31/2022
• Device Model Number: PC4100517-30
• Device Catalogue Number: PC410051730
• Device Lot Number: S14305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1