MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC410073030
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial/final mdr report being submitted with associated mfr# 2954740-2017-00091 and 2954740-2017-00092.(b)(4).Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned by the end user/hospital before being returned which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace of other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location and measurement callouts are approximate and for reference only.Both coils from the same complaint were returned with the coils unprotected and entangled, this unreported damage was not reported.Unreported damage as to why both introducer sheaths of both coil were not returned was not explained.Coil was damaged and was found in a knotted condition.No manufacturing defects were found.The circumstances of how and when the unreported damage and how the missing product components occurred cannot be determined, however a portion of this unreported damage might have been during the end user post-procedural mishandling, cleaning, and packaging.The complaint of the coil being blocked in the unidentified microcatheter is not confirmed.The root cause of the reported failure cannot be determined due to the damaged condition of the coil and without the return of the introducer sheath.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during the embolization procedure a presidio10 cere 7mm x 30cm and presidio10 cere 6mm x 26cm and a coil were blocked in an unknown microcatheter.The procedure was completed using same like products.There were no adverse events.It was reported that the patient had a history of subarachnoid hemorrhage prior to the procedure.It was reported that the complaint products are available for investigation.

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6548663
• Report Number: 2954740-2017-00091
• Device Sequence Number: 13745748
• Product Code: HCG
• UDI-Device Identifier: 00878528003038
• UDI-Public: (01)00878528003038(17)180114(10)C15194
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K082739
• 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
• Report Date (Section B): 04/12/2017

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: 01/14/2018
• Device Catalogue Number: PC410073030
• Device Lot Number: C15194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Initial Report FDA Received Date: 05/05/2017
• Patient Sequence Number: 1