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

Catalog Number	PC410041230
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone: (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, a presidio 10 coil (pc410041230/c41462) could not be detached 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
Conclusion: as reported by a healthcare professional, a presidio 10 coil (pc410041230/c41462) could not be detached 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.Three attempts to obtain additional information were unsuccessful.If additional information is received at a later date, the file will be updated at that time.The device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The distal tip of the green introducer was adhered to part of the inner pouch label and was gently detached.The embolic coil is located in the translucent introducer sheath.A segment of embolic coil protrudes from the skive in the translucent introducer sheath.There is a bend in the translucent introducer sheath at the point of protrusion.There are no kinks or bends apparent in the dpu core wire.There are kinks in several locations along the embolic coil.The rh coil appears to have received heat and melted.The articulating joint is partially obscured by the translucent introducer sheath, but appears to be missing some solder on the proximal end (distal end of the rh coil).The v-notch is undamaged.The resistance of the device was tested.The resistance was 51.9, which is within the specification range of 48.5 ¿ 56 for this product.Detachment cannot be tested because the protrusion of the embolic coil from the translucent introducer sheath prevents advancing the coil 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 of failure to detach is confirmed.The rh coil has received heat and melted, yet the embolic coil is still attached to the dpu.The evidence of the kinks in the embolic coil and the protrusion of the coil from the skive of the translucent introducer sheath suggest that the device was subject to excessive force.The missing solder may have prevented the heat from being transferred to the detachment fiber, resulting in the reported failure to detach.The solder joint on the distal end of the rh coil is verified 100% in-process during manufacture of the dpu.Thus, it is unlikely that the solder was missing when the device left the manufacturing facility.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: 6819837
• Report Number: 2954740-2017-00235
• Device Sequence Number: 1522588
• Product Code: HCG
• UDI-Device Identifier: 00878528003007
• UDI-Public: (01)00878528003007(17)210228(10)C41462
• 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): 08/02/2017

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: 02/28/2021
• Device Catalogue Number: PC410041230
• Device Lot Number: C41462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/19/2017
• Patient Sequence Number: 1