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

Catalog Number	CRC14061530
Medical Device Problem Codes	Positioning Failure (1158); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial mdr submitted for this complaint with associated mfr# 2954740-2016-00329.(b)(4).The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
As reported by a health care professional, during coil intervention a cashmere coil (crc14061530/c35338) did not detach.The procedure was dual microcatheter coiling of a left side anterior communicating artery aneurysm in a 65 year old female patient.The aneurysm dimensions were neck 4.6 mm and dome 6.6 mm.The same connecting cable and detachment box was used with five other coils and except the reported coil there was no problem with detachment.There was 15 minutes of delay due to the reported event; the batteries were changed, connecting cable was changed, detachment however the coil did not detach after 4 attempts.The other codman coil (lot unknown) in the second microcatheter was detached with no problem.The complaint product was removed and replaced with a same like product.It was reported that a pre-deployment electrical check was performed and all connections appeared to fit properly without application of excessive force.The detachment light did not illuminate during the detachment cycle.The complaint coil was still attached to the delivery system upon removal; however was found to be stretched.There were no patient consequences and patient outcome was reported to be fine.It was initially reported that the complaint product is available for analysis.
Additional Manufacturer Narrative
This is follow-up mdr report# 1 submitted for this complaint with associated mfr# 2954740-2016-00329.Limited information was received.The lot number for the detachment control box (dcb) #005943 is from the obsolete black dcb manufactured in april of 2007 which uses replacement batteries.It is highly recommended that the end user return the obsolete black dcb (#005943) for a replacement by the current blue enpower dcb.The dcb (lot #005943) and the connecting cable utilized in this complaint 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 callouts are approximate and for reference only.The coil was returned stretched at the protrusion site with the remainder of the coil undamaged inside the introducer sheath.The protrusion was unreported and no mechanical sheath damage was found at the protrusion site the detachment fiber did not receive heat and melt.The device positioning unit (dpu) passed electrical testing with resistance at 52.4 ohms (range 48.5/56.0) and the test enpower and cable systems ready green light illuminated (cashmere ifu).The coil detached on the first detachment cycle.Post-detachment inspection found that the enpower systems ready green light remained illuminated and the resistance passed at 52.4 ohms.Post-detachment inspection found that the detachment fiber received heat and melted as designed.The field complaint of the coils non-detachment could not be duplicated.No manufacturing defects were found.The complaint of the coils non-detachment cannot be confirmed.The dpu passed electrical testing and the coil was detached on the first detachment cycle, therefore the root cause of the coils non-detachment or the failure of the enpower systems green light to illuminate during the pre-deployment check cannot be determined.In addition, without the return of the old black detachment system, with its batteries and the unidentified microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.Furthermore, it is highly recommended that the end user return the obsolete black dcb (#005943) for a replacement by the current blue enpower dcb.The complaint of the coil found to be stretched is confirmed.While the exact root cause of the coil stretching cannot be determined, the evidence as received highly suggests that the most likely contributing factor may have occurred when the dpu and the coil protruded outside the introducer sheath; the coil was anchored inside the sheath causing the coil to stretch.The circumstances of how and when the unreported dpu/coil protrusion took place cannot be determined.A review of the manufacturing documentation associated with this lot (c35388) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint of the coil¿s non-detachment cannot be confirmed.The dpu passed electrical testing and the coil was detached on the first detachment cycle, therefore the root cause cannot be determined.The complaint of the coil found to be stretched is confirmed; procedural factors related possibly contributed to the 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.

• 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: 6210915
• Report Number: 2954740-2016-00329
• Device Sequence Number: 13563916
• Product Code: HCG
• UDI-Device Identifier: 00878528004561
• UDI-Public: (01)00878528004561(17)200531(10)C35388
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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,Followup
• Report Date (Section B): 12/08/2016

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: 05/31/2020
• Device Catalogue Number: CRC14061530
• Device Lot Number: C35388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 01/11/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICRUS DETACHMENT BOX LOT# 005943
• Patient Age: 65 YR
• Patient Weight: 70