MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) OG TDL CMPLX FILL COIL 4X12; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CF0412
Medical Device Problem Codes	Premature Activation (1484); Material Separation (1562); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity was not provided.Procode: krd/hcg.Concomitant med products due to character limitation: prowler select lpes microcatheter (606s155x/17734584).(b)(6).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.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 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 1226348-2018-00609 & 3008264254-2018-00526.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of a supraclinoid internal carotid artery (ica aneurysm, strong resistance was encountered while advancing the 4x12 orbit galaxy tdl complex fill (640cf0412/17482867) hydraulic coil through the midshaft of the prowler select lpes microcatheter (606s155x/17734584).The coil got stuck and could no longer advance.Upon removal, the coil was detached in the midshaft of the microcatheter, before the proximal marker.Additional information received indicated that the embolic coil prematurely detached in the microcatheter.It was stated that ¿the coil got break in the midshaft of microcatheter it was unable to push further so when we tried to pull the delivery wire detached coil was not moving at all¿.The difficulty required that the coil and microcatheter be removed together as a unit.The coil and microcatheter were replaced to complete the procedure.There was no report of consequence or impact to the patient.The surgery was delayed 10 minutes due to the event.The complaint coil was the first coil used in the case.The coil delivery system was prepped without any difficulty.No visible product damage was noted prior to use.An adequate continuous flush was maintained through the microcatheter.No resistance was encountered between the guidewire and microcatheter when accessing the target site.There were no apparent kinks in the microcatheter that may have contributed to the event.The user did not fasten the rotating hemostasis valve too tightly around the introducer.The user continuously verified that the introducer tip and microcatheter hub remained aligned.The user verified that the flush lines were open and properly pressured when the unusual friction occurred during advancement.The user verified that the clear tab was unlocked and pulled out from the re-sheathing tool approximately one inch.Reportedly, the user did not apply excessive force at any time during the procedure.Of note, the stock was stored in consignment at the hospital.The embolic coil is inside the microcatheter shaft and will be returned for analysis.The microcatheter will be returned in the original packaging of the complaint coil.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 a supraclinoid internal carotid artery (ica) aneurysm, strong resistance was encountered while advancing the 4x12 orbit galaxy tdl complex fill (catalog #: 640cf0412/lot #: 17482867) hydraulic coil through the midshaft of the prowler select lpes microcatheter (catalog #: 606s155x/lot #: 17734584).The coil got stuck and could no longer advance.Upon removal, the coil was detached in the midshaft of the microcatheter, before the proximal marker.Additional information received indicated that the embolic coil detached in the microcatheter.It was stated that ¿the coil got break in the midshaft of microcatheter it was unable to push further so when we tried to pull the delivery wire detached coil was not moving at all¿.The difficulty required that the coil and microcatheter be removed together as a unit.The coil and microcatheter were replaced to complete the procedure.There was no report of consequence or impact to the patient.The surgery was delayed 10 minutes due to the event.The complaint coil was the first coil used in the case.The coil delivery system was prepped without any difficulty.No visible product damage was noted prior to use.An adequate continuous flush was maintained through the microcatheter.No resistance was encountered between the guidewire and microcatheter when accessing the target site.There were no apparent kinks in the microcatheter that may have contributed to the event.The user did not fasten the rotating hemostasis valve too tightly around the introducer.The user continuously verified that the introducer tip and microcatheter hub remained aligned.The user verified that the flush lines were open and properly pressured when the unusual friction occurred during advancement.The user verified that the clear tab was unlocked and pulled out from the re-sheathing tool approximately one inch.Reportedly, the user did not apply excessive force at any time during the procedure.Of note, the stock was stored in consignment at the hospital.No further information was provided.A non-sterile orbit galaxy cmplx xtrasoft coil 2x2 was received inside of a pouch.The hypotube was visually inspected and no damage was observed.The introducer was unzipped without any damage.The support coil, the gripper, and the headpiece of the embolic coil was received outside of the introducer.The remainder of the embolic col was not returned for evaluation.The gripper and the headpiece with some loops of coil were inspected under microscope.The gripper was not damaged.The soldered section between the headpiece and the coil loops was not fractured which is indicative of the solder having a good adhesion to the headpiece.The outer diameter (od) of the delivery tube was measured and was found within specification.Functional analysis could not be conducted due to the condition of the received device.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 expiration date was reviewed (04/30/2018) and the investigation of the sales this lot revealed that it was sold prior to its expiration.The complaint that the coil was separated was confirmed.The headpiece was received attached to the gripper, but the remainder of the embolic coil was not returned for evaluation.The complaint that the coil delivery system was impeded in the microcatheter could not be evaluated as the introducer was unzipped and could not be rezipped.The complaint that the expiration date was exceeded was confirmed.The device history record review revealed that the product was manufactured on 5/3/2016 and expired on 4/30/2018.The reported event date was (b)(6) 2018, which indicates that the product was utilized after it had expired.The complainant verified that the ¿use by¿ date on the outer box and inner package was 4/30/2018, which suggests that the labeling on the device was correct.The specific circumstance that led to this incident of using an expired product could not be obtained.With review of the analysis and the device history records, there is no indication of any manufacturing issues related to the reported event.100% of devices are inspected for damage at final inspection.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.The root cause could not be conclusively determined; however, it is possible that circumstances of the procedure may have contributed to the reported event.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.A non-sterile prowler select lpes microcatheter was received inside of a pouch.The device was inspected and no damage was observed.The inner diameter (id) and outer diameter (od) were measured and found within specification.A review of the manufacturing documentation associated with this lot revealed that one unit was rejected due to the defect "ptfe with wrinkles" and could be related to the reported complaint.However, the device history review confirmed that the rejected unit was properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.The microcatheter was flushed with a lab sample syringe.A.014¿ lab sample guidewire was then introduced into the hub of the received microcatheter and the guidewire could be advanced through the entire length of the microcatheter without any difficulty.Although functional testing could not be performed with the received coil, a sample guidewire was able to advance completely through the microcatheter.Therefore, the complaint that the catheter was obstructed could not be confirmed.Neither the device history record review nor the information available for review indicate that there is a design or manufacturing-related issue.The root cause could not be conclusively determined; however, it is possible that circumstances of the procedure may have contributed to the reported event.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 1226348-2018-00609 & 3008264254-2018-00526.

• Brand Name: OG TDL CMPLX FILL COIL 4X12
• 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: 7556250
• Report Number: 1226348-2018-00609
• Device Sequence Number: 13523989
• Product Code: KRD
• UDI-Device Identifier: 10886704030270
• UDI-Public: 10886704030270
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/10/2018

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: 04/30/2018
• Device Catalogue Number: 640CF0412
• Device Lot Number: 17482867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1