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

Catalog Number	PC410073030
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).It was reported that the device was available to be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, a presidio 10 coil (pc410073030/c41214) stretched during the procedure.They used another one to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
As reported by a healthcare professional, a presidio 10 coil (pc410073030/c41214) stretched during the procedure.They used another one to complete the procedure.There was no report of patient injury.Multiple attempts to obtain additional information were unsuccessful.The device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The distal end of the translucent introducer sheath was tightly wrapped around the coiled device.There is a kink in the green introducer.There are bends in the translucent introducer sheath where it was wrapped around the coiled device.The distal end of the embolic coil is located in the translucent introducer sheath.A segment of embolic coil protrudes from the skive of the translucent introducer sheath where the sheath is bent.The device positioning unit (dpu) core wire protrudes from the skive of the translucent introducer sheath near the resheathing tool.There is a bend in the dpu core wire approximately 22 cm from the proximal end.The skive of the translucent introducer sheath is open where the sheath is bent.The ball tip is intact.There are no kinks or stretched sections in the embolic coil.The protruded section of embolic coil could not be visualized under microscopy.The condition of the articulating joint and resistance heating (rh) coil are obscured by the translucent introducer sheath.However, the articulating joint appears to be properly aligned.The v-notch of the resheathing tool is undamaged.An attempt was made to advance the embolic coil out of the introducer to visualize the articulating joint and rh coil.The embolic coil began to exit the introducer through the opening in the skive at the bend in the translucent introducer sheath.However, the articulating joint and rh coil could not pass around the bends in the introducer (described in the visual examination), and advancement was halted.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 that the embolic coil stretched during the procedure was not confirmed.There were no stretched sections in the embolic coil.The protruded section of embolic coil appears to be related to the tight bends in the translucent introducer sheath, which were apparently a result of coiling the device for return.The bends in the green introducer and dpu core wire and the protrusion of the dpu core wire near the resheathing tool may also be related to preparing the device for return, or they may be evidence of application of excessive force during the procedure.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.
Additional Manufacturer Narrative
The device was returned for analysis on 18 oct 2017; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

• 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: 6907986
• Report Number: 2954740-2017-00280
• Device Sequence Number: 795338
• Product Code: HCG
• UDI-Device Identifier: 00878528003038
• UDI-Public: (01)00878528003038(17)210131(10)C41214
• 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,Followup
• Report Date (Section B): 09/08/2017

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: 01/31/2021
• Device Catalogue Number: PC410073030
• Device Lot Number: C41214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/18/2017; 11/27/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/08/2017; 11/27/2017
• Patient Sequence Number: 1