MAUDE Adverse Event Report: SEE H.10 MICRUSFRAME14 6MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR140615
Medical Device Problem Codes	Difficult To Position (1467); Premature Activation (1484); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2018
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).Concomitant med products: guidewire (chikai 14, asahi intecc), guiding catheter (6fr shuttle sheath), microcatheter (stryker, sl-10), detachment control box (dcb2).Initial reporter information such as the name, phone and email address are unknown.[conclusion]: the healthcare professional reported that during the coil embolization procedure targeting a vertically long aneurysm at the distal portion of the anterior cerebral artery (aca), the micrusframe14 6 mm x 15 cm (mfr140615 / s13658) was used the physician attempted to place the coil in the aneurysm but experienced positioning difficulty as the coil herniated in and out of the lesion.It was determined that the coil was oversize for the lesion.The coil prematurely detached in the microcatheter (stryker, sl-10) during the retrieval attempt even though current was not applied.The micrusframe14 coil remained in the microcatheter and as a result, both the coil and the microcatheter were removed using a foreign body removal catheter for vessels (covidien, goose neck snare).The micrusframe14 coil was replaced and the procedure was successfully completed without further issues or delay.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.Investigation summary: the introducer was not returned.The proximal end connector and strain relief has been removed from the device positioning unit (dpu) and was not returned.The embolic coil is detached and was not returned.There are no apparent kinks or bends in the dpu core wire.The detachment fiber is broken.The resistance heating rh coil has not heated.There is blood visible on the rh coil and extended coil section of the dpu.Microscopic evaluation of the separated proximal end of the dpu suggests that the device was cut.A review of manufacturing documentation associated with this lot (s13658) 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.Investigation conclusion: the complaint that the embolic coil detached prematurely is confirmed.The rh coil has not heated and the detachment fiber is broken.The complaint of positioning difficulty cannot be confirmed from the condition of the returned device.The returned device is incomplete.The introducer, connector and strain relief, and embolic coil were not returned.The exact circumstances of the reported event are unknown, and the concomitant microcatheter was not returned.While the returned device does not show evidence of the application of excessive force, such as kinks in the dpu core wire, excessive force could have been applied to the device in the retraction direction, which would then not leave obvious indications on the returned device.Excessive retraction force, especially with the embolic coil constrained, could have caused the detachment fiber to break, releasing the embolic coil.However, without the return of the concomitant microcatheter and embolic coil, the cause of the reported event cannot be determined.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 targeting a vertically long aneurysm at the distal portion of the anterior cerebral artery (aca), the micrusframe14 6 mm x 15 cm (mfr140615 / s13658) was used the physician attempted to place the coil in the aneurysm but experienced positioning difficulty as the coil herniated in and out of the lesion.It was determined that the coil was oversize for the lesion.The coil prematurely detached in the microcatheter (stryker, sl-10) during the retrieval attempt even though current was not applied.The micrusframe14 coil remained in the microcatheter and as a result, both the coil and the microcatheter were removed using a foreign body removal catheter for vessels (covidien, goose neck snare).The micrusframe14 coil was replaced and the procedure was successfully completed without further issues or delay.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.

• Brand Name: MICRUSFRAME14 6MM X 15CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7602254
• Report Number: 3008114965-2018-00639
• Device Sequence Number: 11118577
• Product Code: KRD
• UDI-Device Identifier: 10886704078005
• UDI-Public: 10886704078005
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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: 03/31/2020
• Device Catalogue Number: MFR140615
• Device Lot Number: S13658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1