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

Catalog Number	MFR100626
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.(b)(4).(b)(6).[conclusion]: the healthcare professional reported that during the coil embolization procedure to treat a subarachnoid hemorrhage (sah) of an aneurysm at the internal carotid-posterior communicating artery (ic-pc), the 6mm x 26cm micrusframe 10 coil (mfr100626 / s13305) was used as a framing coil; the coil was deployed through the sl-10® microcatheter (stryker), but there was poor coil conformability and the coil shape did not fit the target lesion.The physician attempted to resheath the coil, but the introducer sheath became damaged and the coil could not be re-sheathed.The micrusframe 10 coil was replaced with another of the same size and the replacement framing coil was successfully implanted in the target lesion.The procedure was successfully completed without further issues or delay with additional coils successfully implanted at the target lesion.It was confirmed that the coil delivery system was prepped without any difficulty; there was no issue encountered during the unsheathing (stripping away) of the coil introducer tube of the detachable coil system (dcs).The coil introducer was not damaged in anyway prior to use.Excessive force was not used during the unsheathing or resheathing of the device.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 coil was reported as not available to be returned for 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 (s13305) 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 returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information provided in the complaint and without the product available for analysis, the reported customer complaint that there was poor conformability of the coil and that resulted in positioning difficulty of the coil in the target lesion 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.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that procedural and handling factors and/or device interaction with the concomitant microcatheter maybe have contributed to the reported issue that the 6mm x 26cm micrusframe 10 coil did not have good conformability which led to the positioning difficulty in the procedure.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 coil embolization procedure to treat a subarachnoid hemorrhage (sah) of an aneurysm at the internal carotid-posterior communicating artery (ic-pc), the 6mm x 26cm micrusframe 10 coil (mfr100626 / s13305) was used as a framing coil; the coil was deployed through the sl-10® microcatheter (stryker), but there was poor coil conformability and the coil shape did not fit the target lesion.The physician attempted to resheath the coil, but the introducer sheath became damaged and the coil could not be re-sheathed.The micrusframe 10 coil was replaced with another of the same size and the replacement framing coil was successfully implanted in the target lesion.The procedure was successfully completed without further issues or delay with additional coils successfully implanted at the target lesion.It was confirmed that the coil delivery system was prepped without any difficulty; there was no issue encountered during the unsheathing (stripping away) of the coil introducer tube of the detachable coil system (dcs).The coil introducer was not damaged in anyway prior to use.Excessive force was not used during the unsheathing or resheathing of the device.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 coil was reported as not available to be returned for 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: 8376379
• Report Number: 3008114965-2019-00930
• Device Sequence Number: 2253840
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/24/2018

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: 01/31/2020
• Device Catalogue Number: MFR100626
• Device Lot Number: S13305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1