MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, INC. PRE-SHAPED PROWLER MICROCATHETERS; CES MICROCATHETERS (KRA)

Catalog Number 606151MX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2014

Event Type  malfunction  

Event Description

The physician advanced the first coil 6x15 (details unknown) into the prowler14 microcatheter (606151mx/15848979), but he didn¿t like the shape and moved back into the introducer sheath.He changed to smaller size orbit galaxy g2 complex tdl fill, 4mmx10cm (641cf0410/c17354).When he advanced the second coil, the coil got stuck 1/3 into microcatheter.So he re-advanced coil into sheath and he moved the microcatheter back, flushed with heparin saline by syringe, there were only few drops of heparin saline flowing at the tip of microcatheter.He pushed the guidewire (neuroscout14 std) through this microcatheter and it got stuck 1/3 into microcatheter, same as coil.He noticed that there was no coil (4x10mm) in the introducer sheath.The coil was found inside the microcatheter.There were no other damages noted on the coil after use.He tested connecting system of this coil, it still showed green light.Finally, he used a new microcatheter (details unknown) and the operation was performed successfully.This is the doctor¿s third case of coil embolization.The target vessel was pcom which was not calcified and not tortuous.

Manufacturer Narrative

Review of lot 15848979 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The product will not be returned for analysis and additional information will be submitted within 30 days of receipt.Concomitant medical products and therapy dates: guidewire (neuroscout14 std); first coil 6x15 (details unknown); orbit galaxy g2 complex tdl fill, 4mmx10cm (641cf0410/c17354); new microcatheter (details unknown).This is 1 of 3 reports associated with (b)(4).

Manufacturer Narrative

The physician advanced the first coil 6x15 (details unknown) into the prowler14 microcatheter (606151mx/15848979), but he didn¿t like the shape and moved back into the introducer sheath.He changed to smaller size orbit galaxy g2 complex tdl fill, 4mmx10cm (641cf0410/c17354).When he advanced the second coil, the coil got stuck 1/3 into microcatheter.So he re-advanced coil into sheath and he moved the microcatheter back, flushed with heparin saline by syringe, there were only few drops of heparin saline flowing at the tip of microcatheter.He pushed the guidewire (neuroscout14 std) through this microcatheter and it got stuck 1/3 into microcatheter, same as coil.He noticed that there was no coil (4x10mm) in the introducer sheath.The coil was found inside the microcatheter.There were no other damages noted on the coil after use.He tested connecting system of this coil, it still showed green light.Finally, he used a new microcatheter (details unknown) and the operation was performed successfully.This is the doctor¿s third case of coil embolization.The target vessel was pcom which was not calcified and not tortuous.(b)(4).The prowler 14 microcatheter was returned with the detached and stretched coil inside.The proximal length containing the hub and strain relief of the microcatheter was found to be severed and not returned.Approximately midway off the proximal severed end; the microcatheter was severed with the stretched coil protruding out of both severed ends.Located off the distal end of the resheathing tool, the core wire protrudes outside the sheath for a length of 15.0 centimeters.There is no mechanical damage at the core wires protrusion site.Located of the distal tip of the microcatheter is a series of severely compressed sections starting at 6 millimeters, with the remaining 1.5, 4.0, 4.8, 5.5, 7.3, 13.0, 13.9, 18.9, 20.6, 21.0, and 30.0 (all in centimeters except as noted).The circumstances of how and when these multiple sections of damage occurred to the microcatheter cannot be determined as all microcatheters are inspected prior to final packaging.The coils unintended detachment was mechanical in nature.The coil was found to be completely stretched and severed in multiple sections.No material defects were found to the sections of the coil that were returned.The locking mechanism has compression and stretching damage.The proximal severed end of the microcatheter was dissected by the end user.The mid-point severed microcatheter section was also dissected by the end user with the stretched coil protruding out of both the severed microcatheter ends.The distal tip of the microcatheters diameter was ovalized.There are two possible contributing factors to the coil becoming stuck inside the microcatheter and its unintended detachment; however it should be noted that both devices were returned severely destroyed by the end user in attempting to recover the coil or find its location.These possible contributing factors may have worked in tandem or separately with each capable of producing similar results.The primary contributing factor may have been due to distal interference.It is important to note that the first coil advanced through the microcatheter with no issues reported.Then after that time frame the microcatheter was removed and flushed which was found to be obstructed and the guide wire also could not be advanced through the microcatheter.This obstruction was most likely the detached coil.The evidence suggests that either a compressed or ovalized section of the microcatheter caused the coil to become stuck and was detached during removal or secondly, that the constant pressurized flush was interrupted when the first coil was retracted and replaced with a second coil.This may have caused the formation of detached debris in the form of a blood, protein, and contrast to produce an obstruction to the coils advancement and its eventual becoming stuck and anchored inside the microcatheter.However, it is possible that an unknown third form of interference inside the microcatheter may have produced an obstruction capable of causing the coil to become stuck inside the microcatheter followed by an unintended detachment during removal of the device positioning unit (dpu).The secondary contributing factor to the coil becoming stuck and its unintended detachment during removal may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism may have caught the inside of the v notch of the resheathing tool and/or the locking mechanism may not have been fully disengaged off the core wire.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which may have produced coil damage which may have caused the coil to become stuck inside the microcatheter.When the anchored coil was retracted, it may have stretched and had an unintended mechanical detachment inside the microcatheter.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿hold the introducer sheath (loosely-looped) in the left hand.Keeping the introducer tip near the re-sheathing tool, grasp the distal end of the re-sheathing tool between your left thumb and forefinger.Grasp the clear tab near the end of the introducer sheath body with the thumb and forefinger of your other hand.Gently pull the clear tab of the introducer sheath out and away from the re sheathing tool at a 45-degree angle to unlock the microcoil.Continue to pull the tab until an additional 0.5 to 1.0 inches (1.3 to 2.5 cm) of the translucent material is exposed.Gently fold the translucent tab towards the distal end, and firmly grasp the distal end of the re sheathing tool and the translucent tab between your thumb and forefinger, as shown in figure 3¿¿ caution: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the resheathing tool approximately 1in.(2-3cm).¿ based on the information and the analysis, the event coil premature detachment was confirmed but the event dcs impeded-in mc and catheter (body/shaft) obstructed were not confirmed.A review of the manufacturing documentation associated with these lots presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.This is 1 of 3 reports associated with (b)(4).

• Brand Name: PRE-SHAPED PROWLER MICROCATHETERS
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3942465
• MDR Text Key: 4601416
• Report Number: 1058196-2014-00191
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K003925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 606151MX
• Device Lot Number: 15848979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2014
• Initial Date FDA Received: 07/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1