MAUDE Adverse Event Report: REFER TO SECTION H10 MICRUSPHERE XL 8MMX25CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SSR10082520
Medical Device Problem Codes	Kinked (1339); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Based on the product analysis completed on 14-jun-2018, this product event now meets the required criteria for mdr reporting as a "malfunction".Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.(b)(4).(b)(6).(b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of a basilar aneurysm, two micrusphere xl coils (ssr10082520/p10735) and (ssr10082520/s10024) could not be pushed into the unspecified microcatheter.There was no report of consequence or impact to the patient.Multiple attempts to obtain additional information were unsuccessful.The device was returned with its inner pouch.Labeling on the inner pouch matched the product documented in the complaint.The distal end of the embolic coil was located in the green introducer.The device was almost fully sheathed.There was a bend in the device positioning unit (dpu) core wire approximately 118 cm from the proximal end, in the sheathed section.The ball tip was intact.The embolic coil was stretched and kinked.The articulating joint was misaligned.The condition of the resistance heating (rh) coil was obscured by the translucent introducer sheath.The v-notch of the resheathing tool was undamaged.An attempt was made to advance the embolic coil out of the introducer.Damage to the embolic coil prevented it from advancing.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the device was impeded was confirmed.Damage to the embolic coil prevented it from being advanced out of the introducer.The circumstances surrounding the reported event are unknown, and the cause of the damage to the embolic coil is not apparent from the condition of the returned device.However, stretching is generally caused by the application of excessive retraction force while the device is constrained from moving.Also, misalignment of the articulating joint is likely due to application of excessive advancement force to the device, again while it is constrained from moving.The cause of the constraint is not apparent from the condition of the returned device.100% of devices are inspected for damage at quality control (qc) final inspection.In addition, 100% of devices are inspected at final assembly by advancing the embolic coil out of the introducer and retracting it back.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage to the embolic coil and articulating joint.With review of the analysis and the device history records, there is no indication of any manufacturing issues related to the reported event or damages noted on the returned system.Although a definitive conclusion cannot be made, based on the analysis it appears that procedural and handling factors, including device interaction, may have contributed to the event and damages noted on the returned device.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the reported complaint and the associated manufacturer report number is 3008114965-2018-00650.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of a basilar aneurysm, two 8mm x 25cm micrusphere xl coils (ssr10082520/(b)(4)) and (ssr10082520/(b)(4)) could not be pushed into the unspecified microcatheter.There was no report of consequence or impact to the patient.No further information was provided.

• Brand Name: MICRUSPHERE XL 8MMX25CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7609525
• Report Number: 3008114965-2018-00649
• Device Sequence Number: 16557305
• Product Code: KRD
• UDI-Device Identifier: 00878528009962
• UDI-Public: 00878528009962
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032872
• 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): 04/03/2018

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: SSR10082520
• Device Lot Number: P10735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1