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	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 (b)(4) stretched when filling during the procedure.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 (pc410051730/c40176) stretched when filling during the procedure.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.Multiple attempts to obtain additional information were unsuccessful.The device was returned with its inner pouch.The labeling on the inner pouch matches the device documented in the complaint.The embolic coil is stretched and tangled around the dpu and introducer.The resheathing tool has been advanced to the middle of the green introducer.The end of the embolic coil is located in the green introducer, distal to the resheathing tool.There is a kink in the green introducer approximately 1 cm from its proximal end.The embolic coil protrudes from the translucent introducer sheath approximately 1.5 cm from the junction with the green introducer.There is a severe bend in the dpu core wire just proximal to where it meets the tip coil, and another bend approximately 11 cm from the first.The embolic coil could not be disentangled from the dpu.The ball tip is intact.There is blood in the green introducer.The embolic coil is stretched and kinked.The articulating joint is damaged.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 was stretched was confirmed.The coil was stretched, kinked, tangled, and protruding from the introducer.In addition, the articulating joint was damaged.The location of the resheathing tool in the middle of the green introducer indicates that the user unsheathed the device too far.According to the instructions for use (ifu), the user should leave approximately 1 inch of the translucent introducer sheath still visible distal to the resheathing tool.If the proximal end of the embolic coil passes through the resheathing tool, then there is a risk that the coil will emerge from the skive of the translucent introducer sheath, as has happened in this instance.Damage to the coil, articulating joint, green introducer, and dpu core wire also suggests that excessive force was applied to the device.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: 6819861
• Report Number: 2954740-2017-00237
• Device Sequence Number: 1600486
• Product Code: HCG
• UDI-Device Identifier: 00878528003014
• UDI-Public: (01)00878528003014(17)201231(10)C40176
• 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: foreign
• 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: 12/31/2020
• Device Catalogue Number: PC410051730
• Device Lot Number: C40176
• 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: 10/18/2017
• Patient Sequence Number: 1