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

Catalog Number	CRC14061530
Medical Device Problem Codes	Positioning Failure (1158); Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary: very limited information was received.The detached coil was not returned.The unspecified enpower detachment control box (dcb and the unknown connecting cable were not returned.The estream 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 callouts are approximate and for reference only.The coil was not returned.The detachment fiber partially melted.Device positioning unit (dpu) passed electrical testing with resistance at 52.1 ohms (range 48.5/56.0) (mps-prp0243) (fluke meter id# 70042-04d) and the enpower (id#f79684) and cable (id#c10702) systems ready green light illuminated (cashmere ifu).No manufacturing defects were found.It was not stated why the detached coil was not returned.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.Therefore no additional corrective actions are taken at this time.Conclusion: the complaint of the coils non-detachment cannot be confirmed.The dpu passed electrical testing and the detached coil was not returned, therefore the exact root cause of the non-detachment cannot be determined, however the evidence as received highly suggests that the most likely contributing factor may have been the partially melted detachment fiber that may have temporarily anchored the coil to the dpu.It is possible that a loss of fiber tension many have caused the fiber to lose contact with the resistive heating coils heating surface on one side.The circumstances that may have produced the detachment fibers possible loss of tension cannot be determined.In addition, without the return of the coil, the complete detachment system, the estream microcatheter, and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.The complaint of the unintended coil detachment during removal is confirmed.Without the return of the coil, the estream microcatheter, and the rhv used in the procedure, the exact root cause of the coil's unintended detachment in the rhv cannot be determined, however the evidence as received highly suggests that the partially melted detachment fiber temporarily anchored the coil until it entered the rhv at which time an unintended detachment occurred.It cannot be determined if the introducer sheath was retracted during this time frame when the coil was passing through the rhv which if it was would be a secondary contributing factor to the coils unintended detachment.In addition without the return of the detached coil, the estream microcatheter, and the rhv used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.
Event or Problem Description
The contact from the facility reported that during coil embolization at the internal iliac artery the cashmere coil (crc140615-30/c27116) could not be detached.The procedure was the coil embolization at the internal iliac artery.The patient's vessels were moderately torturous and not calcified.A sheath introducer (medikit), a guide wire (gt 14), a guiding catheter (4f jr), a micro catheter (estream str, tokai medical), and an enpower were also used for this procedure.An approach was taken from the left femoral artery with the guiding catheter and the micro catheter to the origin of the right internal iliac artery.Three coils were embedded as a filling in the target lesion without any issue.For the fourth coil, the cashmere (complaint product) was delivered to the lesion with the same detaching devise.However the coil was not detached after pressing the detachment button.After the physician pressed the detachment button for four times without any detachment, the coil was retracted from the lesion.Then the coil was detached unintentionally at the hub of a y connector.The coil was exposed from the y connector, so it was completely removed from the patient.Two more coils were implanted in the lesion without any issue.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to and after the event.The product will be returned for the investigation.No further information is available.

• 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: 6104919
• Report Number: 2954740-2016-00272
• Device Sequence Number: 974783
• Product Code: HCG
• UDI-Device Identifier: 00878528004561
• UDI-Public: (01)00878528004561(17)190529(10)C27116
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2016

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: 05/29/2019
• Device Catalogue Number: CRC14061530
• Device Lot Number: C27116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 11/15/2016
• Patient Sequence Number: 1
• Patient Age: 86 YR