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

Model Number PC418205030J

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2014

Event Type  No Answer Provided  

Event Description

The complaint presidio was the 1st coil to be used in the procedure.It was reported that the presidio coil (pc4182050-30 / j10597) and an enpower control cable (ecb000182-00 / c25932) could not be detached.The complaint cable was replaced with another enpower cable, but no avail.The presidio was replaced with another coil (lot unknown), and the procedure was completed without further issues.However, due to the event it was delayed for 10 minutes, but there was no clinical significance.There were no patient injury/complications.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.Prior to use, no defect (kink, bends, etc.) was noted on the products by visual inspection.Also no visible damages were reported on the devices after the events.Since, the complained products have already been safely disposed, they are not available for analysis.No further information is available.The procedure was the coil embolization of the ccf.The patient was a (b)(6) male of unknown weight.The patient¿s vessels were mildly tortuous but not calcified.It was reported that an unspecified 7fr long sheath by terumo, a chikai 14 (asashi intecc), an envoy (xb mpc 6fr 90cm type, lot unknown), an excelsior 1018 str (stryker, type unknown), and an enpower dcb and a cable (lots unknown) were also used for the above procedure.

Manufacturer Narrative

The device was not returned for analysis.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 failure reported by the costumer as failure to detach was not confirmed, since the device was not return for analysis.The cause of the failure experienced by costumer and the damages found on the device could not be conclusively determined.The dhr suggest that the failure reported could not be related to the manufacturing process and procedural factors appear to have contributed to have the damages.Additionally, inspections are in place to prevent these kinds of failures from leaving from the facility.Therefore, no corrective action will be taken at this time.This report is for (b)(4).

• 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: 4297213
• MDR Text Key: 5269190
• Report Number: 2954740-2014-50053
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K002056
• 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
• Report Date: 11/21/2014

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: 04/30/2017
• Device Model Number: PC418205030J
• Device Catalogue Number: PC418205030J
• Device Lot Number: J10597
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1