MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PRESIDIO 10 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number PC410073030

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

The contact at the hospital reported that the presidio cerecyte coil (pc410073030/(b)(4)) stretched during embolization of a posterior communicating artery with size of 8.5x7.6 mm, neck width 4.27 mm.The surgeon did stent assisted coil embolization and put the microcatheters (details unknown) in place.When the surgeon positioned the coil, he noted that the shape was not satisfactory.He withdrew the coil into the microcatheter, adjusted the position of the microcatheter and tried to re-position the coil.The coil had partly stretched.The surgeon had removed this coil and changed to new coils (details unknown) to complete.There was no report on patient injury.There was no significant delay to the procedure as a result of the issue.There are no product names or lot numbers for the microcatheters or other coils in the complaint.An adequate continuous flush was maintained through the catheter.There was no resistance between the guidewire and microcatheter when accessing the target site.There was no resistance at any time during advancement of the coil through the microcatheter.There were no kinks in the microcatheter.The microcatheter was positioned over the coil while the coil was being deployed out of the distal end of the microcatheter.A one to one relationship between the coil & delivery tube was not verified with fluoro prior to repositioning.After stretching was noted, the entire coil was successfully removed from the patient with the microcatheter and still attached to the delivery system.Upon initial contact, the product was available for return.

Manufacturer Narrative

The product is available for evaluation and testing, however, the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.

Manufacturer Narrative

Only the detached coil was returned with the proximal severed section of the coil not being returned.It was found that the proximal section was unraveled out of the soldered section.The fracture is ductile in nature requiring external force.No manufacturing or material defects were found on the damaged coil.The device positioning unit (dpu) with the sheath and resheathing tool were not returned.The unidentified microcatheter was not returned.While the exact root cause of the coil stretching cannot be determined it is highly likely that the contributing factor may have occurred during repositioning with the coil becoming anchored.The coil may have been temporarily anchored by the coils already dwelling in the aneurysm (if previously placed), on itself, the stent, or on the distal tip of the unknown microcatheter.When the coil was retracted for repositioning, the temporarily anchored coil most likely stretched.The exact circumstances of how and when the coil was severed cannot be determined as it was reported in the complaint event that, ¿after stretching was noted, the entire coil was successfully removed from the patient with the microcatheter and still attached to the delivery system.¿ it was also reported in the complaint event that, ¿a one to one relationship between the coil & delivery tube was not verified with fluoro prior to repositioning¿, therefore for optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿caution: if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.Caution: if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the catheter at or slightly inside the ostium of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.¿ in addition, without the return of the proximal section of the severed coil, the complete dpu with the introducer sheath and attached resheathing tool, and the unidentified microcatheter used in the procedure, it cannot be determined if these components contributed 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 damages found during analysis on the device may have occurred during shipping, because it was noted that the device was not damaged after the event.Based on the information and the analysis, the event was confirmed, however procedural factors outlined in the ifu likely contributed to the event.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, review of 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 10 - 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: 4325898
• MDR Text Key: 5209486
• Report Number: 2954740-2014-50055
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2014

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: 06/16/2018
• Device Catalogue Number: PC410073030
• Device Lot Number: C19025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2014
• Initial Date FDA Received: 12/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2013
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: MICROCATHETERS (DETAILS UNKNOWN)