MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC DELTAMAXX - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CDX18052030

Device Problems Knotted (1340); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2015

Event Type  malfunction  

Event Description

The contact at the hospital reported that during stent-assisted coil embolization of the dissecting aneurysm at the celiac trunk artery the deltamaxx (cdx180520-30 / c31998) experienced resistance when inserting into the microcatheter.The patient was a female of unknown dob, whose vessels were neither tortuous nor calcified.Trans-cell technique was conducted for the embolization of the aneurysm.A prowler select plus (lot unknown), and an enpower dcb / cable (lots unknown) were used for this procedure.After a several deltamaxx (lots unknown) were successfully implanted into the aneurysm, the complaint deltamaxx was chosen next.However, the physician experienced a severe resistance when started inserting the dpu into the mc after setting the introducer sheath into the y-connector.The deltamaxx was withdrawn from the y-connector, and it was discovered that the microcoil was knotted.A new coil was used instead, and the procedure was completed without further issues.The procedure was delayed for 3 minutes due to the event, but the delay was not clinically significant as there were no patient injury/complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and no excessive force was used when inserting the dpu.The constant flush had been maintained at all times.No visible defect/damage was noted on the product prior to the event.The complained product will be returned for analysis.No further information is available.

Manufacturer Narrative

Concomitant devices: prowler select plus microcatheter (lot unknown); enpower dcb / cable (lots unknown).The product has been returned for analysis but has not yet been evaluated.When the device is evaluated the results will be submitted within 30 days and conclusions will be made at that time.The dhr review has been completed.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

As reported, the coil was returned protruding and knotted outside the distal tip of the green introducer.There is coil damage in the knotted section.The remainder of the coil is undamaged.The tip coil section has compression and buckling damage.The coil¿s socket ring has been pushed off to the side.The distal tip of the device positioning unit (dpu) and the proximal end of the coil are no longer concentric to each other.No manufacturing defects were found.The evidence highly suggests that the most likely contributing factor to the coils resistance during insertion into the microcatheter and its eventual knotting may have occurred inside the hub to microcatheter junction.In order for the coil to knot it had to have been in the large funnel void where the area was large enough to knot.The coil cannot be knotted inside the introducer sheath or in the microcatheter¿s tube as both inner lumens are too small.It is highly likely that the distal tip of the green introducer was not fully seated and/or misaligned against the hub to microcatheter junction, but was a distance off this mark which created a void for the coil to entangle around itself and not enter the microcatheter¿s tube.It is also possible that the rotating hemostatic valve (rhv) was not tightened sufficiently to prevent the green introducer from backing away from the hub to microcatheter junction.This produced the resistance encountered during the attempted insertion of the coil into the microcatheter and the coils entanglement.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿loosen the main valve of the rhv attached to the infusion microcatheter hub.Gently insert the introducer tip into the rhv until it can go no further and is in close alignment with the hub of the infusion microcatheter.(there may be a small space, as shown in figure 4, between the tip and hub depending on the type of microcatheter used.) gently tighten the rhv main valve around the introducer sheath to prevent back flow of blood.Visually inspect the alignment of the introducer tip and the microcatheter hub to ensure they have not slipped apart.Fig.4: aligning the introducer tip.Caution: do not fasten the rhv valve too tightly around the introducer sheath since excessive pressure may cause damage to the introducer sheath and/or the microcoil as it is advanced into the infusion microcatheter.Additionally, if the introducer tip and microcatheter hub are misaligned, damage may occur to the microcoil as it passes through this transition.In addition, without the return of the prowler select plus microcatheter and the rhv used in the procedure, it cannot be determined if these components contributed to the complaint event.Dhr: 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.Based on the information and the analysis, the event was confirmed, however procedural factors outlined in the ifu likely contributed to the event.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, review of this lot 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.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 4734156
• MDR Text Key: 20020246
• Report Number: 2954740-2015-00098
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K120274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: CDX18052030
• Device Lot Number: C31998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1