MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MSPHERE 10 PLAT 6MMX11.9CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SPH10060020
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This initial mdr is the only report being submitted for mfr report #3008114965-2018-00568.Additional patient information was requested; however, could not be provided.Krd/hcg.Scepter balloon catheter xc, 7f 10cm terumo sheath, 6f envoy mpd 100cm, prowler sl10, headliner guidewire.012, synchro standard wire.014.(manufacturing site name): codman and shurtleff inc., (b)(4).The device has been forwarded to codman for evaluation; however, the analysis has not been completed.Additional information will be provided within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a micrusphere 6mm x 11.0cm coil (sph10060020/c27844) had stretched during an aneurysm coiling procedure.The physician advanced the coil without any issues, but realized it was too big for the aneurysm and removed it.When the coil was removed, the physician noticed that part of the coil was stretched at the proximal portion.The patient's outcome was fine and the procedure was successfully completed.The patient's vessel characteristics were standard.There was no delay in procedure as a result of the reported event and no medical intervention was required to the patient.A scepter balloon catheter xc, 7f 10cm terumo sheath, 6f envoy mpd 100cm, prowler sl10, headliner guidewire.012, and a synchro standard wire.014 were also used during the procedure.There was no damage noted to the coil, coil delivery system, or coil detachment system prior to the procedure.The coil was still attached to the delivery system when it was removed from the patient.There were no kinks or bends noted to the microcatheter that may have contributed to the reported event.It was noted that the scepter balloon catheter xc may have had a leak as it was not providing adequate occlusion.
Additional Manufacturer Narrative
Product complaint # (b)(4).This final mdr will be the only report submitted for mfr the initial report.Conclusion: the device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The distal end of the embolic coil is located in the green introducer.A section of embolic coil appears to be stretched.The device is partially sheathed.The resheathing tool is broken.There is a bend in the device positioning unit (dpu) core wire approximately 88 cm from the proximal end.The ball tip is intact.The embolic coil is stretched.The articulating joint is intact.The condition of the resistance heating (rh) coil is obscured by the translucent introducer sheath.While the resheathing tool is broken, its v-notch is undamaged.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint that the embolic coil is stretched is confirmed.The proximal end of the embolic coil is stretched.Stretching occurs when excessive force is applied to retract the device while it is prevented from retracting.100% of devices are inspected for coil length at quality control (qc) final inspection.Since stretching alters the length of the device, a stretched device would be detected at the dimensional inspection.Therefore, it is very unlikely that the device was stretched when it left the manufacturing facility.The stretched coil, broken resheathing tool, and bend in the dpu core wire are indicative of the application of excessive force to the device.The cause for the application of excessive force cannot be clearly identified from the condition of the returned device.There is no current safety signal identified related to the reported event based on review of complaint history for the device.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.

• Brand Name: MSPHERE 10 PLAT 6MMX11.9CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 7333969
• Report Number: 3008114965-2018-00568
• Device Sequence Number: 16202353
• Product Code: KRD
• UDI-Device Identifier: 00878528003564
• UDI-Public: 00878528003564
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K142429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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: 06/30/2019
• Device Catalogue Number: SPH10060020
• Device Lot Number: C27844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1