MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PRESIDIO 18 - CERECYTE MICROCOIL; CNV DCS COILS

Model Number N/A

Device Problems Positioning Failure (1158); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

The contact at the hospital reported that during the post-endovascular aneurysm repair of coil embolisation of the patient¿s left subclavian artery a presidio coil (b)(4) was stuck in the prowler select plus (b)(4) and could not be detached using the enpower control cable (b)(4).The patient¿s vessels were heavily tortuous and heavily calcified.It was reported that an okay ii (goodman, type unknown), and an enpower dcb (lot unknown) were also used for the above procedure.The complaint presidio was the 3rd coil to be inserted.It was reported that the dpu of the complaint presidio was stuck inside the mc while the physician was placing the microcoil into the target lesion site.Thus, the physician was unable to maneuver the presidio to fully place the microcoil into the target site.Since almost the entire microcoil was already placed in the target site, the physician attempted to detach the coil.However, despite pressing the detach button a number of times, the physician was unable to detach the microcoil.The physician concluded that to continue using the complaint presidio would be hazardous, therefore it was safely removed together with the complaint prowler from the patient.The microcoil was also safely removed.With a new presidio, prowler, and cable (all details unknown), the physician was able to complete the procedure without further issues or delay.The complaint products were 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.No visible defect (kink, bends, etc.) were noted on the devices prior to the events.A pre-deployment electrical check was performed and there was no report of any abnormal behavior of the dcb.The green system ready light illuminated.During the detachment cycle the detachment light illuminated.All connections appeared to fit properly without application of excessive force.Due to the fact that the patient was a hcv carrier, the complained products have already been safely disposed.No further information is available.

Manufacturer Narrative

Concomitant products: prowler select plus (b)(4); enpower control cable (b)(4); okay ii (goodman, type unknown); enpower dcb (lot unknown); another presidio coil, prowler microcatheter, and connecting cable (all details unknown).The device history record (dhr) is being reviewed and has not yet been completed.No conclusions are made at this time.A supplemental report will be sent with the results.

Manufacturer Narrative

The presidio ((b)(4), lot c25202) will not be returned, therefore the root cause of the coil becoming stuck inside the microcatheter and its inability to be detached cannot be determined.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, the event could not be confirmed.The product was not returned for analysis; however 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.Therefore, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 18 - 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: 4375406
• MDR Text Key: 5267164
• Report Number: 2954740-2014-50067
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2019
• Device Model Number: N/A
• Device Catalogue Number: PC418083030
• Device Lot Number: C25202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2015
• Date Device Manufactured: 04/16/2014
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 78 YR