MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) OG CMPLX FILL COIL 3X8; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0308
Medical Device Problem Codes	Off-Label Use (1494); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).The product lot number was not reported.The product is not available for analysis.Additionally, the sterile lot number is not known.No further analysis can be performed for complaints reported without a lot number and for which the associated products will not be returned.Concomitant med products due to character limitation: gt (terumo) guidewire, progreat¿ (terumo) microcatheter, dcs syringe ii, 5f unspecified contrast catheter.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).[complaint conclusion] as reported by a healthcare professional, during a coil embolization for bleeding caused by an incorrectly punctured branch of the left superficial femoral artery, contrast was performed and confirmed that the 3mm x 8cm orbit galaxy complex fill (640cf0308/unk lot) coil and 3.5mm x 9cm orbit galaxy complex fill (640cf3509/unk lot) coil flowed to the ¿periphery¿.Additional information received indicated that the coils ¿flew into further peripheral vessel¿.Details surrounding the procedural outcome of this situation were not able to be obtained, but no patient complications occurred as a result of the event.The coils had not been detached when the issue occurred.The procedure was completed successfully without further incident or delay.Approach was made via the right superficial femoral artery with a 5f contrast catheter.The microcatheter was approached to the superficial femoral artery branch.A 2mm x 2cm orbit galaxy complex fill coil was anchored.Two competitor coils were placed, and the coils were not coiled densely.A contrast was performed which confirmed that the 3mm x 8cm orbit galaxy complex fill (640cf0308/unk lot) flowed to the periphery.The 3.5mm x 9cm orbit galaxy complex fill (640cf3509/17701254) was inserted and due to the portion of the catheter being adjusted, the coil was attempted to be re-sheathed, but the sheath got stuck and the coil could not be re-sheathed.A contrast was performed and confirmed that the 3.5mm x 9cm orbit galaxy complex fill (640cf3509/unk lot) flowed to the periphery.The physician decided to give up nbca glue and coiled the main as much as possible.A 3mm x 8cm orbit galaxy complex fill was placed.A 3mm x 6cm orbit galaxy complex fill was placed and the catheter was used to push the coil mass to get it to stay in the target site.A 3mm x 8cm orbit galaxy complex fill was firmly deployed at the target site.Contrast was performed which confirmed that ¿it did not flow which means the coils were deployed successfully¿.The complaint products were new and stored per labeling instructions.The coil delivery systems were prepped and used according to the instructions for use (ifu).The procedure was conducted in accordance with the ifu and a constant flush was maintained.No visible product defect/damage was noted prior to the event.There was no difficulty unsheathing the introducer tube from the delivery tube of the coil delivery system.No unintended detachment was observed in the vessel or in the microcatheter.The user did not apply excessive force at any time during the procedure.No further information was provided.The 3mm x 8cm orbit galaxy complex fill was not returned for evaluation.In addition, the sterile lot number was not available; therefore, a review of the manufacturing documentation could not be performed.With the limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.In addition, without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process of the unit.The ifu states that the microcoil delivery system is intended for endovascular embolization of intracranial aneurysms.The product was used in the superficial femoral artery due to vessel puncture.Although the cause of the event could not be clearly established, it is possible that the off-label use of the device and procedural/handling factors may have contributed to the coil migration.The peripheral vessel puncture was likely a shallow opening to be filled; therefore, making coil packing more challenging.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2018-00753 & 1226348-2018-00754.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization for bleeding caused by an incorrectly punctured branch of the left superficial femoral artery, contrast was performed and confirmed that the 3mm x 8cm orbit galaxy complex fill (640cf0308/unk lot) coil and 3.5mm x 9cm orbit galaxy complex fill (640cf3509/unk lot) coil flowed to the ¿periphery¿.Additional information received indicated that the coils ¿flew into further peripheral vessel¿.Details surrounding the procedural outcome of this situation were not able to be obtained, but no patient complications occurred as a result of the event.The coils had not been detached when the issue occurred.The procedure was completed successfully without further incident or delay.Approach was made via the right superficial femoral artery with a 5f contrast catheter.The microcatheter was approached to the superficial femoral artery branch.A 2mm x 2cm orbit galaxy complex fill coil was anchored.Two competitor coils were placed, and the coils were not coiled densely.A contrast was performed which confirmed that the 3mm x 8cm orbit galaxy complex fill (640cf0308/unk lot) flowed to the periphery.The 3.5mm x 9cm orbit galaxy complex fill (640cf3509/17701254) was inserted and due to the portion of the catheter being adjusted, the coil was attempted to be re-sheathed, but the sheath got stuck and the coil could not be re-sheathed.A contrast was performed and confirmed that the 3.5mm x 9cm orbit galaxy complex fill (640cf3509/unk lot) flowed to the periphery.The physician decided to give up nbca glue and coiled the main as much as possible.A 3mm x 8cm orbit galaxy complex fill was placed.A 3mm x 6cm orbit galaxy complex fill was placed and the catheter was used to push the coil mass to get it to stay in the target site.A 3mm x 8cm orbit galaxy complex fill was firmly deployed at the target site.Contrast was performed which confirmed that ¿it did not flow which means the coils were deployed successfully¿.The complaint products were new and stored per labeling instructions.The coil delivery systems were prepped and used according to the instructions for use (ifu).The procedure was conducted in accordance with the ifu and a constant flush was maintained.No visible product defect/damage was noted prior to the event.There was no difficulty unsheathing the introducer tube from the delivery tube of the coil delivery system.No unintended detachment was observed in the vessel or in the microcatheter.The user did not apply excessive force at any time during the procedure.The products will not be returned for evaluation.No further information was provided.

• Brand Name: OG CMPLX FILL COIL 3X8
• 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: 7954399
• Report Number: 1226348-2018-00753
• Device Sequence Number: 288796
• Product Code: KRD
• UDI-Device Identifier: 10886704030225
• UDI-Public: 10886704030225
• 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
• Report Date (Section B): 09/25/2018

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 Catalogue Number: 640CF0308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1