MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSPHERE XL 18 SYSTEM PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SSR18154020
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial mdr report being submitted for this complaint with associated mfr# 2954740-2016-00324.(b)(4).The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.
Event or Problem Description
It was reported by the contact at the user facility that during a coil embolization procedure the first coil used a micrusphere xl 15mm x 40 cm ((b)(4)) coil could not be detected by the detachment box.The green led light did not illuminate when the connecting cable was connected to the hub of the coil.All the connections were checked after which the connecting cable was changed, however the light still did not illuminate.A pre-deployment electrical check was not performed with the complaint coil.The complaint coil was removed and was still attached to the delivery system; no damages were noted on the complaint coil.A new coil was used instead.Three coils were then used without issues.Pre-deployment electrical check was performed with all the coils used after the complaint coil.The same connecting cable and detachment control box was used with the subsequent coils.There were no intra or post procedural complications or surgical delays related to device or reported event.The procedure was coil embolization of a partially thrombosed giant top internal carotid artery aneurysm in a (b)(6) year old female patient whose vessels were severely tortuous.It was initially reported that the complaint product is available for return.
Additional Manufacturer Narrative
This is follow-up# 1 mdr report being submitted for this complaint with associated mfr# 2954740-2016-00324.The micrusphere will not be returned; therefore the root cause of then system fault cannot be determined.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 corrective actions will be taken at this time.
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00324.Product returned for investigation: limited information was received.The unidentified detachment control box (dcb) and the unknown connecting cable were not returned.The unidentified micro-catheter was not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition except for under the dpu¿s distal tip of the outer sheath.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 detachment fiber did not receive heat and melt.The device positioning unit (dpu) passed electrical testing with resistance at 52.0 ohms (range 48.5/56.0) and the test enpower and cable systems ready green light illuminated (micrusphere 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 52.3 ohms.The field complaint of the coil¿s non-detachment could not be duplicated.Post-detachment inspection found that the detachment fiber received heat and melted as designed.No manufacturing defects were found.The complaint of the green systems ready light not illuminating could not be confirmed.The dpu passed electrical testing with the dcb¿s systems ready green light illuminating and the coil was detached on the first detachment cycle, therefore the root cause of the dcb system ready green light not illuminating cannot be determined.It was stated that a pre-deployment electrical test was not completed.If the pre-deployment electrical test was not completed, then for optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿verify the functionality of the microcoil delivery system before proceeding with microcoil placement.This needs to be done with the microcoil still in the hoop.To verify proper dcb and microcoil functionality a connecting cable and microcoil must be connected to the dcb unit.After verification of the dcb and connecting cable, turn off power to the dcb and disconnect the connecting cable from the microcoil until the microcoil is ready to be detached.Please refer to the detachment control box instructions for use section, located near the end of this document, before proceeding.¿ in addition, without the return of the complete detachment system and the unidentified 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 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information and analysis, the event was not confirmed.The returned product passed testing and 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 corrective actions will be taken at this time.

• Brand Name: MICRUSPHERE XL 18 SYSTEM PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6192658
• Report Number: 2954740-2016-00324
• Device Sequence Number: 377284
• Product Code: HCG
• UDI-Device Identifier: 00878528009986
• UDI-Public: (01)00878528009986(17)200831(10)P10954
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K142429
• 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,Followup
• Report Date (Section B): 11/30/2016

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: SSR18154020
• Device Lot Number: P10954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/13/2017; 02/02/2017
• Patient Sequence Number: 1
• Patient Age: 70 YR