MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC DELTAPAQ - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CDF10025630

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2014

Event Type  malfunction  

Event Description

The complaint received states that during advancement two coils (deltapaq cerecyte microcoil 5 mm x 10 cm, cdf10051030 / c20373; deltapaq cerecyte microcoil 2.5 mm x 6 cm, cdf10025630 / c20213) were impeded in the microcatheter.There is no information regarding the type of microcatheter, target lesion, patient demographics or outcome of the reported event.There is no report of injury for the patient.Neither the complaint device nor the concomitant devices kinked/bent at any time.There were no noted damages to the device when it was removed from the patient.It had not reached the target site prior to removal.An adequate continuous flush was maintained throughout the procedure.An unknown sl-10 pre-shape 45 microcatheter was used for the procedure.This was the first coil used with this microcatheter (mc), and the mc and two coils were removed after the event.The reported event occurred before the distal part of the mc.This was a lf ica aneurysm.

Manufacturer Narrative

Additional information will be submitted within 30 days of receipt.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.

Manufacturer Narrative

Updated cc: the complaint received states that during advancement two coils (deltapaq cerecyte microcoil 5 mm x 10 cm, cdf10051030 / c20373; deltapaq cerecyte microcoil 2.5 mm x 6 cm, cdf10025630 / c20213) were impeded in the microcatheter.Neither the complaint device nor the concomitant devices kinked/bent at any time.There were no noted damages to the device when it was removed from the patient.It had not reached the target site prior to removal.An adequate continuous flush was maintained throughout the procedure.An unknown sl-10 pre-shape 45 microcatheter was used for the procedure.This was the first coil used with this microcatheter (mc), and the mc and two coils were removed after the event.The reported event occurred before the distal part of the mc.This was a lf ica aneurysm.There is no report of injury for the patient.(b)(4).As viewed through the returned packaging it was observed that the coil was not attached to the device positioning unit (dpu) and that the exposed and detached coil was found to be severely damaged and stretched.The proximal section of the coil has been severely stretched.The distal coil section has been damaged, but has retained its helical secondary shaping.Due to post-procedural handing, packaging, and the lack of report clarification, it cannot be determined to what extent the coil was damaged and/or detached during or after the procedure.It can be seen with the naked eye that the distal tip of the dpu received heat electrically and melted.The coil was detached when the detachment button was pressed on the detachment control box (dcb).The exact circumstance of why and when this occurred cannot be determined as it was not reported in the event description.Located off the proximal end at 30.0 centimeters and 143.5 centimeters are two severe kinks to the core wire.The detachment fiber received heat and melted.The outer sheath over the resistive heating coil has been melted.The melted outer sheath exhibits damage from either an air detachment or that the detachment button was pressed multiple times.The exact circumstances cannot be determined and were not reported.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been fractured.The locking mechanism has compression and stretching damage.There are two possible contributing factors to the coils impedance inside the microcatheter.These contributing factors may have worked separately or in tandem with each capable of producing similar results.The primary contributing factor to the coil advancement difficulty 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 caught the inside of the v notch of the resheathing tool and became embedded.In addition, the locking mechanism may not have been fully disengaged off the core wire.The sheath also caught the v notches extended edges.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 caused the core wire to severely kink in multiple places, produced a portion of the coil damage found, and would have caused the coils advancement difficulty as experienced by the end user.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).¿ in addition, without the return of the sl-10 microcatheter and the rotating hemostatic valve (rhv) used in the procedure, it cannot be determined if these components had any other additional contributions to the complaint event.The secondary, but equally important contributing factor to the coils impedance inside the microcatheter may have occurred if the detachment button was pushed during this time frame.If the coil was detached inside the microcatheter, then there would have been a great degree of difficulty in advancing a detached coil which may have also have produced a portion of the damage found to the coil.However, it was not reported in event description that the coil was detached and severely damaged, therefore the exact circumstances and time frame of the coils unintended detachment and its severe damage cannot be definitively determined.After performing the pre-deployment electrical testing of the microcoil system, the dpu should be disconnected from the connecting cable to prevent unintended coil detachment.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿¿verify the functionality of the codman microcoil delivery system before proceeding with microcoil placement.This needs to be done with the microcoil still in the hoop.To verify proper dcb and microcoil functionality a connecting cable and microcoil must be connected to the dcb unit.After verification of the dcb and connecting cable, turn off power to the dcb and disconnect the connecting cable from the microcoil until the microcoil is ready to be detached.Please refer to the detachment control box instructions for use section, located near the end of this document, before proceeding¿¿ 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.(b)(4).As viewed through the returned packaging, the partially unsheathed coil was found to be entangled around the core wire and the electrical connector.The distal section of the coil was found to be severely damaged in multiple locations.Due to the post-procedural handling and packaging of the exposed coil it cannot be determined when and how much the coil was damaged during the procedure if at all.The coil¿s socket ring has been pushed down under the outer sheath.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been fractured with sections of the damaged edge being raised above the surface plane.The locking mechanism has compression and stretching damage.The most likely contributing factor to the coil being impeded in the microcatheter 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 caught the inside of the v notch of the resheathing tool and became embedded.In addition, the locking mechanism may not have been fully disengaged off the core wire.The sheath also caught the v notches extended edges.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which pushed the coil¿s socket ring down under the outer sheath and may have produced a portion of the damage found to the coil.In this condition the coil cannot be advanced without extreme difficulty being encountered.This would have given the end user the impression that the source of interference originated 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).¿ in addition, without the return of the sl-10 microcatheter and the rotating hemostatic valve (rhv) used in the procedure, it cannot be determined if these components had any additional contributions to the complaint event.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 complaint could not be confirmed on analysis, secondary to the received state of the complaint devices.100% inspections are in place to prevent damaged products from leaving the facility and the dhr review confirmed that the product met specifications.No corrective action is required at this time.Review of the available information suggests that intra and post procedural issues may have contributed to both the reported difficulties and the damages noted upon product return.

• Brand Name: DELTAPAQ - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3790994
• MDR Text Key: 15124762
• Report Number: 1226348-2014-00098
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2014

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: 07/03/2018
• Device Catalogue Number: CDF10025630
• Device Lot Number: C20213
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN SL-10 PRE-SHAPE 45