MAUDE Adverse Event Report: PRESIDIO 10 CERE 5MMX17CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	PC4100517-30
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by an affiliate, during a coil embolization to an unknown target site, a presidio 10 coil (pc410051730, c36101) stretched.Another coil was used with the same unknown microcatheter (mc) to complete the procedure.There was no report on the patient injury.There was no clinically significant delay in the procedure.The product will be returned for analysis.Adequate continuous flush was maintained through the catheter.There was no report of resistance at any time during advancement of the coil through the mc.There was no resistance when the coil was advanced/repositioned/withdrawn.After stretching was noted, the entire coil was successfully removed from the patient still attached to the delivery system.The device was removed from the mc while the mc remained at the target site.It is unknown if other coils went through the same mc without resistance.No additional information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).As reported by an affiliate, during a coil embolization to an unknown target site, a presidio 10 coil ((b)(4), c36101) stretched.Another coil was used with the same unknown microcatheter (mc) to complete the procedure.There was no report on the patient injury.There was no clinically significant delay in the procedure.Adequate continuous flush was maintained through the catheter.There was no report of resistance at any time during advancement of the coil through the mc.There was no resistance when the coil was advanced/repositioned/withdrawn.After stretching was noted, the entire coil was successfully removed from the patient still attached to the delivery system.The device was removed from the mc while the mc remained at the target site.It is unknown if other coils went through the same mc without resistance.No additional information is available.The device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The device is fully unsheathed.The resheathing tool has been advanced all the way to the green introducer, and the introducer has been pulled back all the way to the hub of the device positioning unit (dpu).The resheathing tool is broken.There is a bend in the dpu core wire at the distal end of the resheathing tool.The dpu is separated at the extended coil.The proximal fragment of the extended coil is attached to the dpu.The distal fragment of the extended coil, the remainder of the distal end of the dpu, and the embolic coil were not returned.There is a second bend in the dpu core wire approximately 97 cm from the proximal end.The extended coil is separated and damaged.While the resheathing tool is broken, its v-notch 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.The complaint that the embolic coil is stretched cannot be confirmed.The embolic coil and the distal portion of the dpu were not returned.The portion of the device that was returned ends with a fragment of the extended coil section of the dpu.The pet sheath around the extended coil has been removed.According to the event description, the entire device was successfully removed from the microcatheter after the embolic coil was observed to be stretched.The circumstances surrounding the separation of the extended coil are not reported.The bends in the dpu core wire and the broken resheathing tool are indicative of the application of excessive force to the device.The reason for the application of excessive force cannot be determined from the condition of the returned device.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 10 CERE 5MMX17CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7196812
• Report Number: 3008114965-2018-00513
• Device Sequence Number: 1497542
• Product Code: HCG
• UDI-Device Identifier: 00878528003014
• UDI-Public: (01)00878528003014(17)200531(10)C36101
• 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: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2017

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: 01/31/2019
• Device Model Number: PC4100517-30
• Device Catalogue Number: PC410051730
• Device Lot Number: C23791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: 12/25/2017
• Supplement Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1