MAUDE Adverse Event Report: SEE H.10 G2 TDL COMPLEX FILL COIL 12X30; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	641CF1230
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.(fremont).Concomitant medical products: medtronic echelon 10 microcatheter.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Product was received and is pending evaluation.The manufacturer will submit a supplemental report once evaluation is completed.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 the carotid-cavernous fistula (ccf), the physician attempted to deploy the g2 complex fill coil 12mm x 30cm (641cf1230 / p10026), he experienced resistance while advancing the coil through the microvention headway microcatheter.The physician removed the g2 coil from the microcatheter and observed that the coil had become stretched.The coil was replaced; the physician was able to complete the case using the same headway microcatheter to deploy seven additional coils.There was no report of any patient consequence or adverse event associated with the reported issue.The g2 coil was indicated as available to be returned for analysis.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure to treat the carotid-cavernous fistula (ccf), the physician attempted to deploy the g2 complex fill coil 12mm x 30cm (641cf1230 / p10026), he experienced resistance while advancing the coil through the microvention headway microcatheter.The physician removed the g2 coil from the microcatheter and observed that the coil had become stretched.The coil was replaced; the physician was able to complete the case using the same headway microcatheter to deploy seven additional coils.There was no report of any patient consequence or adverse event associated with the reported issue.The g2 coil was returned for evaluation.The investigational finding is documented below.Investigation summary: the device was returned with its original packaging label, which matched the complaint information.The device was returned with the device positioning unit (dpu) and embolic coil removed from the introducer sheath.No kinks were observed along the dpu core wire.Blood was seen in the green introducer.The device was then inspected under a microscope.The distal outer sheath was observed to be not softened indicating that the resistance heating coil had not heated, and the detachment process not initiated by a detachment control device.Articulating joint is seen intact.The embolic coil was observed to have a kink; however, the embolic coil was not seen stretched as there were no additional gaps between its primary winds.The embolic coil distal ball tip was present and intact.The v-notch of the resheathing tool was observed to be undamaged.The product could not be tested by advancing through a microcatheter due to the condition in which it was returned.The embolic coil and dpu core wire is physically unable to be reinserted into the introducer sheath once removed to see if the coil can be advanced.During the review of the lot history records of lot p10026, it was noted that two (2) units were rejected due to kinked coils which is an issue 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 coil unraveled/stretched is not confirmed.The embolic coil was not seen stretched or unraveled.There were no gaps with the exception of the one kink along its length were observed.The reported issue related to the resistance experienced during the advancement of the coil through the microcatheter cannot be confirmed.The device could not be advanced due to the condition in which it was returned.It is possible that resistance was encountered as a result of insufficient flushing indicated by the blood observed in the green introducer.The instruction for use (ifu) states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.100% of embolic coils are inspected in-process.It is unlikely that the device left the manufacturing facility with the observed damage.With the information documented in the complaint and the returned device for evaluation, the reported stretched embolic coil was not confirmed.The embolic coil was not stretched not unraveled.With the exception of one kink along the coil length, no gaps were noted in the coil that would indicate a stretched condition.The reported issue with the resistance experienced during the coil advancement was also not confirmed.The residues of dry blood noted on the green introducer suggest that there was likely an insufficient flush maintained, which would likely cause the experienced resistance issue reported.Adequate flush is required for optimal performance; insufficient or inadequate flush can allow for blood to back flow into the microcatheter and can result in resistance.The insufficient flush can be a factor in the positioning difficulty and resistance when the coil was being advanced through the microcatheter.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.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% in-process inspection for any damage to the embolic coil.Thus, it is not likely that the g2 complex fill 12mm x 30cm coil left the manufacturing facility with the embolic coil in a stretched state.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: G2 TDL COMPLEX FILL COIL 12X30
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7851836
• Report Number: 3008114965-2018-00712
• Device Sequence Number: 13746008
• Product Code: KRD
• UDI-Device Identifier: 10878528009662
• UDI-Public: 10878528009662
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120686
• 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,Followup
• Report Date (Section B): 08/13/2018

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: 641CF1230
• Device Lot Number: P10026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROVENTION HEADWAY MICROCATHETER