MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC CASHMERE 14 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CRC14123030

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2014

Event Type  malfunction  

Event Description

It was reported that the cashmere coil (crc141230-30 / (b)(4)) could not be detached despite pressing the detachment button five times.After re-connecting the enpower dcb, the physician re-attempted the detachment, but no avail.Further re-attempts were made by slightly torquing and moving in and out the coil, and after pressing the detachment button four times, the coil was eventually detached.Pre-deployment was conducted prior to inserting and using.After the event, the procedure was completed without further issues by mainly using the competitive products due to the physician¿s apprehension with cashmere.There were no patient injury/complications.There was no report of if the procedure was delayed or not.The complaint product was new and 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 visible damages were reported on the devices after the events.There was no unintended detachment of the coil observed in the vessels or in the mc.Since the actual coil was successfully detached and the dpu and sheath have already been disposed, the complaint product is not available for analysis.No further information is available.The procedure was the coil embolization of a ruptured cerebral aneurysm at the patient¿s ica.The patient¿s sex, dob and weight were unknown.The tortuosity and the calcification level of the patient¿s vessels were also unknown.There was no information of the concomitant devices used in the procedure.It was reported that an enpower dcb and a cable (lots unknown) were used for the above procedure.No further details of the concomitant devices are available.

Manufacturer Narrative

(b)(4).The product will not be returned for analysis, and additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

It was reported that the cashmere coil ((b)(4)) could not be detached despite pressing the detachment button five times.After re-connecting the enpower dcb, the physician re-attempted the detachment, but no avail.Further re-attempts were made by slightly torquing and moving in and out the coil, and after pressing the detachment button four times, the coil was eventually detached.Pre-deployment was conducted prior to inserting and using.After the event, the procedure was completed without further issues by mainly using the competitive products due to the physician¿s apprehension with cashmere.There were no patient injury/complications.There was no report of if the procedure was delayed or not.The complaint product was new and 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 visible damages were reported on the devices after the events.There was no unintended detachment of the coil observed in the vessels or in the mc.Since the actual coil was successfully detached and the dpu and sheath have already been disposed, the complaint product is not available for analysis.No further information is available.The procedure was the coil embolization of a ruptured cerebral aneurysm at the patient¿s ica.The patient¿s sex, dob and weight were unknown.The tortuosity and the calcification level of the patient¿s vessels were also unknown.There was no information of the concomitant devices used in the procedure.It was reported that an enpower dcb and a cable (lots unknown) were used for the above procedure.No further details of the concomitant devices are available.The device was not returned for analysis, and 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 event could not be confirmed, since the product was not returned for analysis.Additionally, with the limited information is not possible to determine if user handling may have contributed to the event.Also, 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: CASHMERE 14 - 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: 4327698
• MDR Text Key: 5214885
• Report Number: 2954740-2014-50058
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K072173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2015

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: 07/28/2018
• Device Catalogue Number: CRC14123030
• Device Lot Number: C20279
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1