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

Catalog Number	PC418083030
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Dhr: a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The device is expected for return but has not yet been returned.Additional information will be provided within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
The contact from the facility reported that during coil embolization, the presidio coil (pc418083030/c23952) stretched.The coil was withdrawn and a new one was used to complete the procedure.There was no report of patient injury.At the time of initial contact the device was available for return.There was no reported significant clinical delay to the procedure as a result of the issue.An adequate continuous flush was maintained through the microcatheter at all times.There was no resistance between the guidewire and microcatheter when accessing the target site.There was no resistance at any time during advancement of the coil through the microcatheter.There were no kinks in the microcatheter.Resistance was not reported when the coil was advanced, repositioned, or withdrawn.
Additional Manufacturer Narrative
The unidentified microcatheter and the rotating hemostatic valve (rhv) were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned before being returned which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location and measurement callouts are approximate and for reference only.No coil stretching was found.The coil retained its secondary framing shape.Full microscopic inspection failed to find any coil stretching along its entire length.No manufacturing defects were found.Dhr: a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Conclusion: the complaint of the coil stretching is not confirmed.No coil stretching was found.The coil retained its secondary framing shape.Full microscopic inspection failed to find any coil stretching along its entire length, therefore the root cause of the coil stretching cannot be determined.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; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6031362
• Report Number: 2954740-2016-00241
• Device Sequence Number: 1079333
• Product Code: HCG
• UDI-Device Identifier: 00878528003205
• UDI-Public: (01)00878528003205(17)190105(10)C23952
• 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): 09/21/2016

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: Other
• Device Expiration Date: 01/05/2019
• Device Catalogue Number: PC418083030
• Device Lot Number: C23952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2016
• Supplement Report FDA Received Date: 11/15/2016
• Patient Sequence Number: 1