MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC CASHMERE 14 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CRC14061530

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2014

Event Type  Injury  

Event Description

The physician placed a cashmere coil (crc140615-30/c23927) into the internal carotid artery aneurysm through a non-codman microcatheter, by using the balloon remodeling technique (brand of balloon unknown).When he was pulling and pushing the coil into the target lesion several times, the coil unintentionally detached at the distal end of the microcatheter and was entirely and safely retrieved from the patient by using a gooseneck snare.The cashmere was replaced for a new product (crc140615-30, lot unknown) and the procedure was successfully completed using the same microcatheter without any further issues.There was no patient injury/complications reported, and the detachment did not result in disruption of blood flow.It is unknown how many coils were successfully placed into the target lesion before the complaint product, but it was reported that the cashmere had not become entangled with other coils and the detachment was not related to an interaction with the balloon catheter or microcatheter.A 1:1 relationship between the coil and delivery tube was verified with fluoroscopy prior to repositioning, and the microcatheter was not positioned at a sharp angle to the microcatheter.The microcatheter had not been reposition.The complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the ifu, and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc) was noted on the product by visual inspection.Also no damages were reported on the device after the event.It is unknown if the microcatheter was re-shaped or not.The complaint product is unavailable for evaluation.No additional information is available.

Manufacturer Narrative

Information regarding patient age, weight, medical history and concomitant medications were not provided.Complaint conclusion: the physician placed a cashmere coil (crc140615-30/c23927) into the internal carotid artery aneurysm through a non-codman microcatheter, by using the balloon remodeling technique (brand of balloon unknown).When he was pulling and pushing the coil into the target lesion several times, the coil unintentionally detached at the distal end of the microcatheter and was entirely and safely retrieved from the patient by using a gooseneck snare.The cashmere was replaced for a new product (crc140615-30, lot unknown) and the procedure was successfully completed using the same microcatheter without any further issues.There was no patient injury/complications reported, and the detachment did not result in disruption of blood flow.It is unknown how many coils were successfully placed into the target lesion before the complaint product, but it was reported that the cashmere had not become entangled with other coils and the detachment was not related to an interaction with the balloon catheter or microcatheter.A 1:1 relationship between the coil and delivery tube was verified with fluoroscopy prior to repositioning, and the microcatheter was not positioned at a sharp angle to the microcatheter.The microcatheter had not been reposition.The complaint product was new and was stored per labeling instructions.The procedure was conducted in accordance with the ifu, and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc) was noted on the product by visual inspection.Also no damages were reported on the device after the event.It is unknown if the microcatheter was re-shaped or not.No additional information is available.The complaint product is unavailable for evaluation.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 and detachment could not be confirmed without return of the device for analysis.The root f the compliant could not be conclusively determined; however, the based on the information provided, the coil may have detached because it was caught with in the aneurysm or on the distal part of the microcatheter.There was no indication of a manufacturing issue related to the event; therefore, no corrective action will be taken.This is an initial/final mdr.

• Brand Name: CASHMERE 14 - 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3865849
• MDR Text Key: 4508063
• Report Number: 1226348-2014-00121
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072173
• 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: 05/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/03/2018
• Device Catalogue Number: CRC14061530
• Device Lot Number: C23927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention