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

Catalog Number	PC418103430
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00221.(b)(4).Concomitant medical products: deltamaxx coil ( lot unknown); helipaq (lot unknown).The presidio will not be returned, therefore the root cause of the coil becoming damaged during resheathing cannot be determined.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during an emergency coil embolization procedure for alimentary canal bleeding a presidio 18 (pc4181034-30/ c14003) coil got damaged when the physician attempted to re-sheath the coil.The procedure was successfully completed without further issues or delay.There were no patient injuries or complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was maintained at all times.No visible defect/damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the microcatheter.The patient's information is unknown.The product is not available for the investigation.No further information is available.
Additional Manufacturer Narrative
This is one of one final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00221.Added event country "(b)(6)" to the initial reporter field.

• 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: 5992852
• Report Number: 2954740-2016-00221
• Device Sequence Number: 13595705
• Product Code: HCG
• UDI-Device Identifier: 00878528003229
• UDI-Public: (01)00878528003229(17)171209(10)C14003
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 09/23/2016

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: 12/09/2017
• Device Catalogue Number: PC418103430
• Device Lot Number: C14003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2016
• Supplement Report FDA Received Date: 10/11/2016
• Patient Sequence Number: 1