MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASHMERE 14 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CRC14051230
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr being submitted for this complaint with associated mfr# 2954740-2016-00216 (b)(4).: very limited information was received.Both the unidentified detachment control box (dcb) and the connecting cable were not returned.The unidentified microcatheter was 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 call outs are approximate and for reference only.The detachment fiber did not receive heat and melt.Device positioning unit (dpu) failed electrical testing with resistance at 34.0 ohms (range 48.5/56.0) and the test enpower and cable systems ready green light failed to illuminate (cashmere ifu).Compression at the distal tip of the resistive heating coil section caused the resistance pass at 53.7 ohms (range 48.5/56.0).No manufacturing defects were found.The complaint of the coils non-detachment is confirmed.While the root cause of the coils non-detachment cannot be determined, the evidence as received highly suggests the most likely contributing factor to the coils non-detachment may have been due to a fracture of the solder joint connection inside the resistive heating coil.The circumstances of how and when this damage occurred cannot be determined as all microcoil systems are tested prior to final packaging.In addition, without the identification or the return of the complete detachment system and the microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.A review of the manufacturing documentation associated with this lot (c37879) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information and the analysis, the event was confirmed.The root cause of the coils non-detachment cannot be determined; the evidence as received highly suggests the most likely contributing factor to the coil's non-detachment may have been due to a fracture of the solder joint connection inside the resistive heating coil.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during coil embolization procedure of right anterior choroidal artery aneurysm a cash 14 cere 5mmx12cm ((b)(4)) could not be detached.A pre-deployment check was performed.There were no damages noted on the coil prior to use or upon removal.The complaint coil was withdrawn and a new coil (type/lot unknown) was used to complete the procedure.The reported event did not require an exchange of the connecting cable or the detachment control box, the same cable and dcb were used for coils prior to and after the reported event.The patient was a (b)(6) female with an aneurysm of size (b)(6).There was no report on the patient injury.There were no intra or post procedural complications or delays related to device or reported event.It was initially reported that the complaint product is available for return.

• Brand Name: CASHMERE 14 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 5980333
• Report Number: 2954740-2016-00216
• Device Sequence Number: 757718
• Product Code: HCG
• UDI-Device Identifier: 00878528004523
• UDI-Public: (01)00878528004523(17)200831(10)C37879
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072173
• 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
• Report Date (Section B): 09/05/2016

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: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: CRC14051230
• Device Lot Number: C37879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2016
• Initial Report FDA Received Date: 09/27/2016
• Patient Sequence Number: 1
• Patient Age: 65 YR