MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) OG CMPLX XTRASOFT COIL 4X8; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX0408
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during a stent-assisted coil embolization of a paraclinoid internal carotid artery aneurysm, the 4x8 orbit galaxy complex xtrasoft (640cf0408/17610075) hydraulic coil was selected for use as a filling coil but the coil migrated into an unintended location through the strut of an unspecified stent which had been placed.Additional information received indicated that the coil did not migrate from the aneurysm back through the stent into the parent vessel, but the coil was accidentally placed through the stent while approaching to the target lesion.The physician attempted to re-sheath the coil, but the zipper became stuck and the coil could not be re-sheathed.The coil was replaced, and the procedure was completed successfully without further incident.No patient complications occurred as a result of the event.The length of procedural delay was not reported; however, the delay was not clinically significant.There was no evidence of flow restriction/reduction due to the event.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and an adequate continuous flush was maintained through the catheter.No product visible damage was noted prior to the event.The coil delivery system was prepped and used as per the ifu.No unintended detachment was observed in the vessel or in the microcatheter.The embolic coil did not detach/break during retrieval.The user did not apply excessive force during the case.A sl-10 (stryker) microcatheter was used for the case.The product is not available for the investigation.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).[complaint conclusion].As reported by a healthcare professional, during a stent-assisted coil embolization of a paraclinoid internal carotid artery aneurysm, the 4x8 orbit galaxy complex xtrasoft (640cf0408/17610075) hydraulic coil was selected for use as a filling coil but the coil migrated into an unintended location through the strut of an unspecified stent which had been placed.Additional information received indicated that the coil did not migrate from the aneurysm back through the stent into the parent vessel, but the coil was accidentally placed through the stent while approaching to the target lesion.The physician attempted to re-sheath the coil, but the zipper became stuck and the coil could not be re-sheathed.The coil was replaced, and the procedure was completed successfully without further incident.No patient complications occurred as a result of the event.The length of procedural delay was not reported; however, the delay was not clinically significant.There was no evidence of flow restriction/reduction due to the event.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and an adequate continuous flush was maintained through the catheter.No product visible damage was noted prior to the event.The coil delivery system was prepped and used as per the ifu.No unintended detachment was observed in the vessel or in the microcatheter.The embolic coil did not detach/break during retrieval.The user did not apply excessive force during the case.A sl-10 (stryker) microcatheter was used for the case.No further information was provided.The device was not available for analysis.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the manufacturing process of the unit.The exact cause of the event could not be conclusively determined; however, it is possible that clinical and procedural factors including aneurysm/vessel characteristics, device interaction, and device manipulation 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.

• Brand Name: OG CMPLX XTRASOFT COIL 4X8
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC (MEXICO); circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580
• MDR Report Key: 7930030
• Report Number: 1226348-2018-00743
• Device Sequence Number: 1914030
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: 10886704030638
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093973
• 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): 09/11/2018

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: 09/30/2018
• Device Catalogue Number: 640CX0408
• Device Lot Number: 17610075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/24/2018
• 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: SL-10 (STRYKER) MICROCATHETER