MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC418113730
Medical Device Problem Codes	Positioning Failure (1158); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, a presidio 18 coil (b)(4) could not be detached during the procedure.They used another coil to complete the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
Additional device code to premature deployment added based on product analysis findings.Conclusion: as reported by a healthcare professional, a presidio 18 coil (pc418113730/c26016) could not be detached during the procedure and the device was returned detached.They used another coil to complete the procedure.There was no report of patient injury.Three attempts to obtain additional information were unsuccessful.If additional information is received at a later date, the file will be updated at that time.The device was returned for analysis.The device was returned with its inner pouch.The labeling on the inner pouch matches the product documented in the complaint.As returned, the device was adhered to the inside of the decontamination pouch by the label of its inner pouch.The device was carefully detached from the label and the decontamination pouch.The embolic coil is not attached to the dpu and was not returned.The dpu core wire has protruded from the translucent introducer sheath distal to the resheathing tool.There are severe kinks in the dpu core wire at the strain relief and at approximately 76 cm from the proximal end.The rh coil has not received heat and melted.There are kinks in the extended coil and marker band.The point and side of the v-notch in the resheathing tool are damaged.The resistance of the dpu was tested.The resistance was 52.0, which is in the acceptance range of 48.5 ¿ 56.Since the embolic coil is not attached, detachment cannot be tested.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint of failure to detach cannot be confirmed because the embolic coil was not returned with the device.However, the fact that the rh coil did not receive heat and melt indicates that there had been no successful detachment cycle.The kinks in the dpu core wire, extended coil, and marker band, along with the mechanical detachment of the embolic coil, are indicative that excessive force was applied to the device.While the exact sequence of events is unknown, application of excessive force could have caused the damage that led to the reported incident.In addition, the damage to the v-notch of the resheathing tool indicates that the user did not properly unlock the introducer before unsheathing.According to the instructions for use (ifu), the device is to be unlocked by gently pulling the tab of the translucent introducer sheath away from the resheathing tool out and away at a 45-degree angle.Pulling the tab straight back will damage the v-notch, and will also require excessive force, which could result in the observed damage.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 event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6819878
• Report Number: 2954740-2017-00239
• Device Sequence Number: 68610
• Product Code: HCG
• UDI-Device Identifier: 00878528003236
• UDI-Public: (01)00878528003236(17)190328(10)C26016
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2019
• Device Catalogue Number: PC418113730
• Device Lot Number: C26016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/18/2017
• Patient Sequence Number: 1