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

Catalog Number PC410051730

Device Problems Difficult To Position (1467); Premature Activation (1484); Material Separation (1562); Stretched (1601); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

Mfg name: codman & shurtleff, inc.Dba depuy synthes products, inc.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 Description

During the aneurysm embolization, the coil could not be shaped as expected.The surgeon withdrew the coil to fill again but the coil could not be advanced.Withdrew the coil and it was found stretched.Used another coil to complete the procedure.There was no report on the patient injury.

Manufacturer Narrative

Additional codes of coil premature detachment and separation added based on product analysis findings.During the aneurysm embolization, the presidio coil (b)(4) could not be shaped as expected.The surgeon withdrew the coil to fill again but the coil could not be advanced.They withdrew the coil, and it was found to be stretched.They used another coil 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 device documented in the complaint.The embolic coil is detached from the device positioning unit (dpu) and has been separated into two pieces.The dpu core wire is protruding from the translucent introducer sheath.There is blood in the translucent introducer sheath.There is a kink in the dpu core wire approximately 26 cm from the proximal end.There is blood on the stretched section of embolic coil.The socket ring, which is at the proximal end of the embolic coil, is intact.The ball tip is intact on the distal section of the embolic coil.There is blood on the distal section of embolic coil.There is stretching evident on the distal section of embolic coil.Microscopic inspection revealed the translucent introducer sheath is kinked at the distal end of the section of protruded dpu core wire.There is fibrous material on the resheathing tool.The v-notch of the resheathing tool is undamaged.The resistance heating (rh) coil is obscured by the green introducer.An attempt was made to advance the rh coil out of the introducer in order to visualize it.The device could not be advanced out of the introducer.Advancement of the embolic coil cannot be tested since the coil is separated, stretched, and detached from the dpu.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The positioning difficulty with the embolic coil cannot be confirmed because the embolic coil was returned damaged and detached from the dpu.The complaint that there was resistance or friction during advancement cannot be confirmed for the same reason.The complaint that the embolic coil was stretched was confirmed.The separated ends of the embolic coil demonstrate that the break is ductile in nature, most likely a result of the same stress that caused the embolic coil to stretch.While the exact circumstances are unknown, the fact that the embolic coil was stretched and separated indicates that excessive force was applied to the device during retraction.While no resistance was reported, the resistance to retraction could have followed the reported positioning difficulty.The user reported removing the entire coil from the microcatheter and finding it stretched, but not separated or detached from the dpu.If the coil had separated or detached while still in the microcatheter, it would not have been possible to remove it for return.Thus, it is likely that the additional damage to the embolic coil (separation and detachment) occurred after it was retrieved from the microcatheter.The protrusion of the dpu core wire from the translucent introducer sheath and the bend in the dpu core wire indicate that excessive force was applied to the device during advancement, possibly in an attempt to overcome the reported resistance.Resistance could have been due to insufficient flush.The presence of blood on the embolic coil suggests that an insufficient flush was maintained.The 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
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 47709 freemont blvd; freemont, CA 94538 ; 9497899383
• MDR Report Key: 6998833
• MDR Text Key: 92048630
• Report Number: 3013875781-2017-00021
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528003014
• UDI-Public: (01)00878528003014(17)210331(10)S10231
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: PC410051730
• Device Lot Number: S10231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1