MAUDE Adverse Event Report: SEE H.10 MICRUSFRAME10 3.5MM X 6.6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100356
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.Procode: procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).(b)(6).[conclusion]: the healthcare professional reported that during the coil embolization procedure of an aneurysm at the internal carotid artery, the 4 mm x 7.5 cm micrusframe 10 coil (mfr100356 / s13055) was delivered into the stryker sl-10® microcatheter but there was resistance between the hub of the microcatheter and the coil.The coil was retracted once and redelivered into the microcatheter, but resistance was experienced at 10 cm from the tip of the microcatheter and the coil could not be advanced further.The micrusframe 10 coil was replaced with another of the same size from the same lot s13055.The replacement coil was delivered to the target lesion using the same microcatheter without any issue; however, the size of the coil did not fit the lesion and it was replaced.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 4 mm x 7.5 cm micrusframe 10 was returned for evaluation and analysis.A kink was observed on the embolic coil.Based on the analysis completed on 1/15/2019, the event meets the required criteria for mdr reporting as a ¿malfunction.¿ the investigational finding is documented below.Investigation summary: the device was returned with the embolic coil advanced from the introducer sheath, leaving the coil exposed.The embolic coil was measured to be approximately 6.6 cm, which is accurate to the product type recorded.The device was also returned with the green introducer positioned inside the distal end of the resheathing tool.No kinks were seen on the device positioning unit (dpu) core wire.The device was then inspected under a microscope.The articulating joint was seen intact.The distal outer sheath had not been softened, indicating that the detachment process had not been initiated.The embolic coil distal ball tip was present and intact.A kink was seen on the embolic coil.The v-notch of the resheathing tool was seen undamaged.The device positioning unit (dpu) core wire was seen protruding from the most distal end of the skive.No kinks were observed on the core wire near this area.The protrusion of the core wire occurred too close to the green introducer.When the coil was sheathed, the flexible core wire protruded out and could not be advanced through a microcatheter.During the review of the lot history records for the lot s13055, it was noted that 1 unit was rejected due to a kinked coil which is a condition that may be associated with the type of failure mode as reported in the complaint.However; the device history record (dhr) review confirmed that all product rejected during manufacturing were identified as scrap and properly accounted for.No other issues were noted that were considered potentially related to the reported complaint.Investigation conclusion: the complaint of detachable coil delivery system (dcs) impeded in microcatheter with no loss of cerebral target position was not confirmed.The unit was returned with the embolic coil advanced from the introducer sheath.When the coil was retracted in preparation of advancing through a lab microcatheter, the flexible dpu core wire protruded as the introducer skive had been damaged and unable to contain the core wire.Because the flexible part of the dpu core wire was exposed, it was not possible to push the dpu distally and advance the coil.The instruction for use (ifu) indicates to leave 2-3 cm of space between the resheathing tool and green introducer when unzipping the device.Advancing the resheathing tool further than this will put strain on the distal end of the skive.This may cause the skive to remain open when attempting to resheath the device and not re-form around the dpu.As a result, the dpu will not properly re-zip.Proper zipping and unzipping functionality is verified for 100% of devices when the introducer lock is formed.Thus, it is unlikely that the device left the manufacturing facility with the observed damage to the introducer or with the dpu core wire protruding from the skive of the translucent introducer sheath.It is unknown during what part of the delivery process the embolic coil was kinked.The microcatheter used during the procedure was not returned for analysis.There is not enough information to determine a cause of the failure.100% of devices are inspected along the entire length of the embolic coil.It is unlikely that the device left the manufacturing facility with the damage observed.Coil kinked is a known potential issue associated with the use of the device.The instruction for use provides proper handling instructions for the device to prevent issues such as kink from occurring.The kink observed on the returned device was not originally reported with the complaint.Review of the device history record confirmed that all product rejected during manufacturing were identified as scrap and properly accounted for.No other issues were noted that were considered potentially related to the reported complaint.The exact cause of the observed kinked coil could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation/interaction may have contributed to kink observed on the embolic coil of the returned device.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 of an aneurysm at the internal carotid artery, the 4 mm x 7.5 cm micrusframe 10 coil (mfr100356 / s13055) was delivered into the stryker sl-10® microcatheter but there was resistance between the hub of the microcatheter and the coil.The coil was retracted once and redelivered into the microcatheter, but resistance was experienced at 10 cm from the tip of the microcatheter and the coil could not be advanced further.The micrusframe 10 coil was replaced with another of the same size from the same lot s13055.The replacement coil was delivered to the target lesion using the same microcatheter without any issue; however, the size of the coil did not fit the lesion and it was replaced.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 product was reported as available to be returned for evaluation and analysis.Evaluation of the returned device revealed a kinked embolic coil.Based on the analysis completed on 1/15/2019, the event meets the required criteria for mdr reporting as a ¿malfunction.¿.

• Brand Name: MICRUSFRAME10 3.5MM X 6.6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 8253914
• Report Number: 3008114965-2019-00884
• Device Sequence Number: 2418344
• Product Code: KRD
• UDI-Device Identifier: 10886704077794
• UDI-Public: 10886704077794
• 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): 10/19/2018

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: 12/31/2019
• Device Catalogue Number: MFR100356
• Device Lot Number: S13055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1