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

Catalog Number	PC410051730
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial mdr will be the only report submitted for mfr report #2954740-2017-00241.The product has been forwarded to codman for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that the presidio coil (pc410051730/c33692) stretched when filling during the procedure.Another one was used to complete the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr report #2954740-2017-00241.The dpu has been removed from the introducer, and the introducer was returned.The embolic coil has been detached from the dpu.The embolic coil was returned tangled around the dpu core wire.The embolic coil was gently disentangled from the dpu.The end of the embolic coil is stretched.There are some kinks in the extended coil and tip coil of the dpu, but no kinks or bends are apparent in the dpu core wire.The rh coil did not receive heat and melt.There is a small amount of blood visible in the end of the green introducer.A small mass of tangled embolic coil wire can be seen in the green introducer.There is a small amount of damage to the v-notch.The ball tip is intact.The proximal end of the embolic coil is stretched and broken.The complaint that the embolic coil is stretched is confirmed; the coil is stretched and broken.The small mass of wire in the green introducer suggests that the embolic coil was broken in the green introducer.While the exact sequence of events is unknown, the damage to only the proximal end of the embolic coil suggests that the larger portion of the coil was deployed when the damage occurred.The damage was caused by application of excessive force to the proximal end of the embolic coil while the distal portion was protected, possibly by being tangled in the deployment location.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.Therefore, 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: 6821922
• Report Number: 2954740-2017-00241
• Device Sequence Number: 67993
• Product Code: HCG
• UDI-Device Identifier: 00878528003014
• UDI-Public: (01)00878528003014(17)200229(10)C33692
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 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: 02/29/2020
• Device Catalogue Number: PC410051730
• Device Lot Number: C33692
• 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: 11/08/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 11/08/2017
• Patient Sequence Number: 1