MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC MICRUSPHERE 10 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CSP10050030

Device Problems Difficult To Position (1467); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

During stent assisted coil embolization of an unruptured aneurysm of the internal carotid/posterior cerebral artery using jailed technique, a micrusphere (csp100500-30 / j10150) was difficult to position within the aneurysm, and the hub became detached.Initially, an enterprise vrd 28mm (lot unknown) was grafted into the parent artery, and a presidio 10x7mm was successfully implanted into the target aneurysm.Next the micrusphere coil was successfully advanced into the aneurysm, but part of the microcoil migrated from the aneurysm wall while looping the microcoil into the coil mass.The physician kept re-winding the microcoil to fit it into the mass, but the hub/connector of the micrusphere became detached from the device positioning unit (dpu).It was reported that excessive force was not applied while maneuvering the coil.The coil was replaced with another coil, and the procedure was completed without further issues or delay.There were no patient injury/complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush had been maintained at all times.No visible defect/damage was noted on the product prior to the event.There was no unintended detachment of the microcoil observed in the vessel or in the microcatheter.The patient¿s vessels were moderately tortuous, but no calcified.No further information was available.

Manufacturer Narrative

Concomitant products: a chikai (asahi intecc, 0.014¿), a launcher (medtronic, 8fr), an excelsior sl-10 (stryker), a prowler select plus (lot unknown), and an enpower dcb / cable (lots unknown) were used for this procedure.Apart from a microsphere, an unspecified number of galaxy and ed coils (kaneka medix) were also used.Patient age and weight were not provided.Complaint conclusion: the device was returned for analysis.The returned device was heat sealed inside bubble wrap which can further damage the device.As viewed through the returned packaging, the coil was found to be entangled around the device positioning unit and sheath.Proximal coil compression and buckling damage was found.As viewed through the returned packaging and as reported, the electrical connector was returned severed.Located off the proximal severed end are two severe kinks on the hypotube at 68.5 and 113.0 centimeters.The dpu and the introducer sheath with the attached resheathing tool were returned separated from each other.When this occurs severe damage will most likely happen to the unit in multiple sections.The electrical connector and hypotubes fracture are ductile in nature requiring external force.Note that viewing the hypotube side of the fracture, a severe bend of the proximal end of the tube is seen.No material defects were found to the fractured ends.No manufacturing defects were found.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 positioning difficulty could not be confirmed due to the nature of the event; however, the hub separation was confirmed by failure analysis.Based on the condition of the returned device, and how it was shipped, it is not possible to determine when the unreported device damage found during analysis occurred.While the exact root cause of the coils positioning difficulty could be determined, the evidence shows that several contributing factors of distal interference may have led to the coils inability to be fully deployed inside the aneurysm.There may have been interference from the coil¿s already dwelling inside the aneurysm (if previously placed), from itself, or from the distal section of the unidentified microcatheter.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿caution: if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.Caution: if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.¿ in addition, without the identification or the return of the unknown microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.It was reported no visible damage was found to the unit prior to use.The most likely final contributing factor to the electrical connectors fracture may have occurred during the repeated repositioning of the coil inside the aneurysm combined with the reported distal interference during the procedure, however the exact circumstances of how and when that produced this damage cannot be determined.The damage to the fracture was ductile in nature which required external force.It was also observed that the hypotube was found to have been severely bent at the fractured end.No material defects were found to the severed ends.Since there was no evidence of a manufacturing issue related to the event, no corrective or preventive actions will be taken at this time.This is an initial/final mdr.

• Brand Name: MICRUSPHERE 10 - 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: 4730036
• MDR Text Key: 5585116
• Report Number: 2954740-2015-00097
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K0022420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/02/2015

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: 05/31/2015
• Device Catalogue Number: CSP10050030
• Device Lot Number: J10150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1