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

Catalog Number	PC418103430
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr will be the only report submitted for this report.The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a presidio18 coil ((b)(4)/c26071) was stretched during a procedure.The physician removed the coil safely and used another of the same size coil to successfully complete the procedure.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr report #2954740-2017-00284.Conclusion: the device was returned unsheathed with the embolic coil tangled around the device positioning unit (dpu).The embolic coil is detached from the dpu.The embolic coil was gently removed from the dpu.The embolic coil is stretched.There is blood in the green introducer and translucent introducer sheath.The resheathing tool is broken.There is a kink in the dpu core wire at the strain relief.There are bends in the dpu core wire approximately 31 cm, 36 cm, 46 cm, 62 cm, 79 cm, 117 cm, 123 cm, and 134 cm from the proximal end.There is a severe bend in the tip coil.The ball tip is intact.There is blood on the embolic coil.The embolic coil is kinked and stretched.The proximal loop of the embolic coil is broken.The detachment fiber is missing and the resistance heating (rh) socket is damaged.The rh coil has not received heat.Microscopic image of blood in translucent introducer sheath.There is blood on the resheathing tool.The v-notch of the resheathing tool is undamaged.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint that the embolic coil is stretched is confirmed.The coil is stretched, kinked, and mechanically detached from the dpu.This damage to the embolic coil, along with the bends in the dpu core wire and the broken resheathing tool, is evidence that excessive force was applied to the device.The bends in the dpu core wire indicates that force was applied during advancement of the device, and stretching of the embolic coil indicates that force was applied during retraction of the coil.While the exact circumstances are unknown, it is possible that the device was stretched as a result of difficulty removing or repositioning the embolic coil.The damage to the dpu core wire may have occurred while trying to overcome resistance to advancement.The presence of blood on the embolic coil, in the translucent introducer sheath, and on the resheathing tool 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 were no significant safety signals identified related to the reported event based on a review of complaint history for the device.Therefore, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6930891
• Report Number: 2954740-2017-00284
• Device Sequence Number: 125476
• Product Code: HCG
• UDI-Device Identifier: 00878528003229
• UDI-Public: (01)00878528003229(17)190430(10)C26071
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• 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): 09/14/2017

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: 04/30/2019
• Device Catalogue Number: PC418103430
• Device Lot Number: C26071
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 01/03/2018
• Patient Sequence Number: 1