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

Catalog Number	PC410073030
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2017
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, during the procedure, the presidio 10 coil (b)(4)could not be detached.They exchanged the coil to complete the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
As reported by a healthcare professional, during the procedure, the presidio 10 coil (pc410073030/c40826) could not be detached.They exchanged the coil to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.Multiple attempts to obtain additional information were unsuccessful.The presidio10 device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The distal end of the embolic coil is located in the middle of the green introducer.There appears to be blood on the embolic coil in the translucent introducer sheath.The device positioning unit (dpu) core wire and tip coil are protruding from the skive of the translucent introducer sheath.The resheathing tool is broken.There are bends in the dpu core wire at the strain relief and approximately 10 cm from the proximal end.The ball tip is intact.There is blood on the embolic coil in the green introducer and the translucent introducer sheath.There are no apparent kinks or stretched sections in the embolic coil.The articulating joint is intact; the resistance heating (rh) coil is obscured by the translucent introducer sheath.An attempt was made to advance the embolic coil out of the introducer in order to visualize the articulating joint and rh coil.Because the tip coil is protruded from the skive of the translucent introducer sheath the embolic coil could not be advanced.The dpu protrudes from the skive of the translucent introducer sheath at the extended coil.While the resheathing tool is broken, its v-notch is undamaged.The resistance of the device was measured and the multimeter was overloaded, which is outside of the specification range of 48.5 ¿ 56 ¿.Detachment functionality cannot be tested because of the overloaded resistance and because the embolic coil cannot be advanced out of the introducer.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 failed to detach is confirmed.With overloaded resistance in the device, it would not be possible to initiate a detachment cycle.The resistance failure is likely a result of the damage to the dpu core wire.Kinks and bends in the dpu core wire are evidence of the application of excessive force, possibly in an attempt to overcome resistance.A kink in the dpu core wire can damage the electrical connection between the device hub and the rh coil, causing the resistance to be out of specification and the detachment cycle to fail.Resistance may have been a result of insufficient flushing, as evidenced by blood observed in the introducer.The instructions for use (ifu) states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.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 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: 6849653
• Report Number: 2954740-2017-00257
• Device Sequence Number: 655421
• Product Code: HCG
• UDI-Device Identifier: 00878528003038
• UDI-Public: (01)00878528003038(17)211031(10)C40826
• 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): 08/21/2017

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: 10/31/2021
• Device Catalogue Number: PC410073030
• Device Lot Number: C40826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 11/15/2017
• Patient Sequence Number: 1