MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 CERE 4MMX11.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	PC4100412-30
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2019
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.The phone and email address of the initial reporter are not available / reported.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 (s12815) 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 aneurysm embolization procedure, the 4mm x 11.5cm presidio 10 cerecyte coil (pc410041230 / s12815) could not be detached.The physician withdrew the complaint coil and replaced it with a new coil to complete the procedure.There was no report of any patient adverse event and patient complication associated with the reported issue.
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 07/15/2020; the returned product underwent evaluation and analysis.Additional information was also received on 7/15/2020, the information is included in this mdr submission.[conclusion]: the healthcare professional reported that during the aneurysm embolization procedure, the 4mm x 11.5cm presidio 10 cerecyte coil (pc410041230 / s12815) could not be detached.The physician successfully withdrew the complaint coil and replaced it with a new coil to complete the procedure.Additional information was provided.The coil was not stretched when it was removed; it was still attached to the delivery system.The same detachment control box was used to detach subsequent coil.It was also reported that a pre-deployement electrical check was not performed and the low battery and fault lights were not seen during the procedure.The reported issue did not cause any clinically significant procedural delay.There was no report of any patient adverse event and patient complication associated with the reported issue.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 4mm x 11.5cm presidio 10 cerecyte coil was returned contained in a pouch.Visual inspection was performed; no damage was observed on the returned device.Microscopic inspection was performed.The embolic coil was observed in good condition, still attached to the device.The resistance heating (rh) coil showed no evidence of having been heated; an indication that the detachment process had not been initiated.Functional analysis: the resistance of the returned 4mm x 11.5cm presidio 10 cerecyte coil was measured with multimeter.The resistance initially measured to be 53.1o; this is within the specification range of 48.5 o ¿ 56.0 o.The device was connected to a detachment control box dcb00000500 (dcb) with a lab sample enpower control cable and the power was turned on.The system ready light was illuminated.The detachment process was initiated and the embolic coil was successfully detached.A review of manufacturing documentation associated with this lot (s12815) 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 4mm x 11.5cm presidio 10 cerecyte coil could not be detached during the procedure was not confirmed.The device was returned; it underwent visual and microscopic inspection with no observable damages.A functional test was performed, and the embolic coil was successfully detached without issue.The reported failure to detach issue could not be duplicated, the returned device did not have any observable damage noted during the visual and microscopic inspection.The device function as expected during the functional evaluation.Based on the manufacturing documentation 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.

• Brand Name: PRESIDIO 10 CERE 4MMX11.5CM
• 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: 10273813
• Report Number: 3008114965-2020-00258
• Device Sequence Number: 16358747
• Product Code: HCG
• UDI-Device Identifier: 00878528003007
• UDI-Public: 00878528003007
• 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): 06/24/2020

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: 11/30/2021
• Device Model Number: PC4100412-30
• Device Catalogue Number: PC410041230
• Device Lot Number: S12815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1