MAUDE Adverse Event Report: SEE H.10 MICRUSFRAME10 6MM X 26CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100626
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.(b)(4).[conclusion]: the healthcare professional reported that during the emergency coil embolization procedure of an aneurysm due to a gastrointestinal bleeding, the micrusframe 10 6mm x 26cm coil (mfr100626 / s13590) could not be advanced at the distal portion of the introducer sheath.The physician attempted to move the coil several times, and the coil became unraveled.The coil entire coil was removed and replaced with another coil of a different size and the procedure continued to successful completion without further issues or delay using several coils of different sizes.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.The micrusframe 10 10 6mm x 26cm coil was reported as not available to be returned for product evaluation and analysis.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (s13590) 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.Product analysis cannot be conducted as the product was not available to be returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Device history lot - a review of manufacturing documentation associated with this lot (s13590) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.With the information provided in the complaint and without the product available for analysis, the reported issue by the customer cannot 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.
Event or Problem Description
The healthcare professional reported that during the emergency coil embolization procedure of an aneurysm due to a gastrointestinal bleeding, the micrusframe 10 6mm x 26cm coil (mfr100626 / s13590) could not be advanced at the distal portion of the introducer sheath.The physician attempted to move the coil several times, and the coil became unraveled.The coil entire coil was removed and replaced with another coil of a different size and the procedure continued to successful completion without further issues or delay using several coils of different sizes.There was no report of patient injury or complication; the complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the instruction for use (ifu) with constant flush maintained at all time.There was no visible defect or damage noted on the product prior to the event.There was no unintended detachment observed in the vessel or in the microcatheter.The micrusframe 10 10 6mm x 26cm coil was reported as not available to be returned for product evaluation and analysis.

• Brand Name: MICRUSFRAME10 6MM X 26CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7895701
• Report Number: 3008114965-2018-00736
• Device Sequence Number: 10792788
• Product Code: KRD
• UDI-Device Identifier: 10886704077862
• UDI-Public: 10886704077862
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• 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
• Report Date (Section B): 08/30/2018

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: 02/29/2020
• Device Catalogue Number: MFR100626
• Device Lot Number: S13590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1