MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) OG HELICAL XTRSOFT COIL 2X4; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640HX0204
Medical Device Problem Codes	Difficult To Position (1467); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity were not provided.Procode: krd/hcg.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.Concomitant med products due to character limitation: orbit galaxy complex xtrasoftl 3.5x7.5 (640cx3575/17685003) hydraulic coil.(b)(6).Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.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 1226348-2018-00535 & 1226348-2018-00536.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of an aneurysm, the surgeon wanted to adjust the position of the 2mm x 4cm orbit galaxy helical xtrasoft (640hx0204/17673404) and the 3.5mm x 7.5cm orbit galaxy complex xtrasoft (640cx3575/17685003) as the coils would not conform to the walls of the aneurysm, but the coils could not be withdrawn back into the unspecified microcatheter.The issue required that the coils and microcatheter be removed as a unit.The coils were successfully removed from the patient and replaced.The same microcatheter was used to complete the case.The surgery was not delayed due to the event.There was no loss of cerebral target position associated with the event.No patient complication occurred as a result of the event.No visible product damage was noted prior to the event.There was no resistance between the guidewire and the microcatheter when accessing the target site.There was no resistance at any time during advancement of the coils through the microcatheter.An adequate continuous flush was maintained through the microcatheter.There were no apparent kinks in the microcatheter.A one-to-one relationship between the coil and delivery tube was verified with fluoroscopy prior to repositioning.There was no report of the coils protruding out of the aneurysm during positioning prior to detachment.The coils were attached to the delivery system when removed from the patient.The coils were not stretched when they were removed.The user did not apply excessive force at any time during the procedure.The coils will be returned for analysis.The associated microcatheter is not available for return.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of an unknown aneurysm, the surgeon wanted to adjust the position of the 2mm x 4cm orbit galaxy helical xtrasoft (640hx0204/17673404) and the 3.5mm x 7.5cm orbit galaxy complex xtrasoft (640cx3575/17685003) as the coils would not conform to the walls of the aneurysm, but the coils could not be withdrawn back into the unspecified microcatheter.The issue required that the coils and microcatheter be removed as a unit.The coils were successfully removed from the patient and replaced.The same microcatheter was used to complete the case.The surgery was not delayed due to the event.There was no loss of cerebral target position associated with the event.No patient complication occurred as a result of the event.No visible product damage was noted prior to the event.There was no resistance between the guidewire and the microcatheter when accessing the target site.There was no resistance at any time during advancement of the coils through the microcatheter.An adequate continuous flush was maintained through the microcatheter.There were no apparent kinks in the microcatheter.A one-to-one relationship between the coil and delivery tube was verified with fluoroscopy prior to repositioning.There was no report of the coils protruding out of the aneurysm during positioning prior to detachment.The coils were attached to the delivery system when removed from the patient.The coils were not stretched when they were removed.The user did not apply excessive force at any time during the procedure.The associated microcatheter is not available for return.No further information was provided.A non-sterile og helical xtrsoft coil 2x4 was received coiled inside of a pouch.The hypotube was visually inspected and was found kinked at 70 and 73 cm from the proximal end.The introducer was found partially zipped, while the support coil was found outside of the proximal end of the introducer.The gripper and embolic coil were found inside of the introducer and no apparent damages were observed.Functional analysis could not be performed as the support coil was located outside of the proximal end of the introducer.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.The reported customer complaint ¿coil - withdrawal difficulty-into microcatheter¿ could not be evaluated as the support coil was found outside of the proximal end of the introducer.The reported customer complaint ¿coil - positioning difficulty-poor conformability" could not be evaluated in the lab, as it is dependent on the operational context.Neither the device history record review nor the product analysis suggest that the reported failures could be related to the manufacturing process of the unit.The exact cause of the event could not be conclusively determined; however, procedural/handling factors and the concomitant microcatheter may have contributed to the reported failures.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2018-00535 & 1226348-2018-00536.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: OG HELICAL XTRSOFT COIL 2X4
• 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: 7352812
• Report Number: 1226348-2018-00535
• Device Sequence Number: 1556477
• Product Code: KRD
• UDI-Device Identifier: 10886704030713
• UDI-Public: 10886704030713
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: 03/31/2019
• Device Catalogue Number: 640HX0204
• Device Lot Number: 17673404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1