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

Catalog Number CDF10015430

Device Problems Difficult To Position (1467); Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2015

Event Type  malfunction  

Manufacturer Narrative

It is unknown at this time if the device will be available 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.Additional information will be submitted within 30 days of receipt.

Event Description

During the stent assisted coil embolization of an ophthalmic artery aneurysm, the deltapaq coil (b)(4) did not conform well to the aneurysm wall, and when repositioning, the surgeon noted the delivery wire herniated from the sheath and could not be resheathed.The device was then removed with the unspecified microcatheter.It was reported that the procedure was performed as per the instructions for use (ifu) and a continuous flush had been maintained through the microcatheter.There was no premature detachment or damage to the actual coil.The surgeon changed to a new coil and microcatheter to complete the surgery.There was no report of patient injury or clinically significant delay in the procedure.The aneurysm was 3.3 x 4.05mm with a neck width of 2.6 mm.The device was not available to be returned.

Manufacturer Narrative

Correction: it was initially reported that it was unknown if the device would be returned; however, the device was returned for analysis on 5/8/2015.Complaint conclusion: the device was returned for analysis.The coil was returned undamaged.The proximal pull tab section containing the locking mechanism has been severed and not returned.The resheathing tool has been separated off the sheath causing the core wires protrusion.The sheath has been severed and cut by an unidentified sharp straight edge tool of unknown origin.There is no mechanical sheath damage at the protrusion site.No manufacturing defects were found.Based on limited information and with the return of the undamaged coil, it cannot be determined why the coil did not conform to the aneurysm wall.Furthermore, it is important to note that it was unreported as to why the unidentified microcatheter was replaced after the complaint coil was removed from the patient.Concerning the resheathing difficulty, it was found that the severing of the sheaths pull tab containing the locking mechanism and ball tip allowed the resheathing tool to separate from the introducer sheath.This allowed the core wire to protrude outside the sheath.In this condition, resheathing the coil cannot be performed.The circumstances of how and when the sheath was severed and not returned cannot be determined.In addition, without the identification or the return of the unknown microcatheter and the severed proximal end of the sheath used in the procedure, it cannot be determined if these components had any contributions to the complaint event.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 coil poor conformity to the aneurysm wall could not be confirmed during product analysis since the coils was returned undamaged.The sheath herniation was confirmed; however, the damage found on the sheath was related to post-procedural damage since it was reported that the sheath was not damaged during use.The root cause of the coil not confirming to the aneurysm and the sheath herniation could not be determined; however, procedural/handling factors may have contributed.There was no evidence of a manufacturing issue related to the event; therefore, no corrective/preventive actions will be taken at this time.

• Brand Name: DELTAPAQ - 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: 4742370
• MDR Text Key: 16611588
• Report Number: 2954740-2015-00105
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080437
• 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,Followup
• Report Date: 04/08/2015

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: 04/22/2018
• Device Catalogue Number: CDF10015430
• Device Lot Number: C17541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2015
• Initial Date FDA Received: 05/01/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR