MAUDE Adverse Event Report: SEE H.10 MSPHERE 10 PLAT 3.5MMX6.6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	SPH10035020
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.(b)(4).Initial reporter information such as the name, phone and email address are unknown.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the procedure, the microsphere 10 platinum coil 3.5mm x 6.6cm (b)(4) was found stretched.The coil was withdrawn and another coil was used to complete the procedure.There was no report of any patient injury or consequence.
Additional Manufacturer Narrative
(b)(4).[conclusion]: the healthcare professional reported that during the embolization procedure of an intracranial aneurysm, the microsphere 10 platinum coil 3.5mm x 6.6cm (b)(4) was found stretched; the issue occurred during the insertion of the coil through the microcatheter (unknown brand).It was not reported if there was any resistance between the guidewire and the microcatheter during the attempt to access the target site.There was no resistance at any time during the advancement of the microsphere coil through the microcatheter; continuous flush was maintained through the microcatheter.There was no kink on the microcatheter that could have contributed to the reported stretched condition of the coil.The entire coil was successfully removed without any other additional damage observed.There was no reduction or restriction of blood flow associated with the reported issue.Another coil was used to complete the procedure; no significant clinical delay was reported.There was no report of any patient injury or consequence.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (p10043) presented no issues during the manufacturing or inspection processes related to the reported complaint.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the limited information available and without the product available for analysis, the reported customer complaint that the microsphere 10 platinum coil 3.5mm x 6.6cm was stretched could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to the reported failure.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.Additional information will be submitted within 30 days of receipt.

• Brand Name: MSPHERE 10 PLAT 3.5MMX6.6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7712915
• Report Number: 3008114965-2018-00664
• Device Sequence Number: 19525860
• Product Code: KRD
• UDI-Device Identifier: 00878528003533
• UDI-Public: 00878528003533
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2018

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: 04/30/2020
• Device Catalogue Number: SPH10035020
• Device Lot Number: P10043
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1