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

Catalog Number PC410051730

Device Problems Failure to Advance (2524); Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The presidio (pc4100517-30, lot c27632) will not be returned, therefore the root cause of strong resistance during advancing and the coil stretching 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.The product was not received for analysis, and without the product, the reported event could not be confirmed.Review of the lot revealed no anomalies during the manufacturing and inspection process that can be associated with the reported complaint.Therefore, no corrective actions will be taken at this time.(b)(4).

Event Description

During the procedure the (gc) guide catheter and sl 10 (mc) microcatheter reached lesion (middle of cerebral artery aneurysm) normally.There was a strong resistance when the presidio 10 cere 5mmx17cm coil (pc410051730/c27632) advanced halfway, but the coil could not advance.The surgeon removed and noted it stretched.The mc and coil were changed to complete the procedure.A constant and dedicated saline source was used at all time, and after the resistance was met, no additional force was used to further advance the device.There was no report on patient injury.No further information was received.

Manufacturer Narrative

During the procedure the (gc) guide catheter and sl 10 (mc) microcatheter reached lesion (middle of cerebral artery aneurysm) normally.There was a strong resistance when the presidio 10 cere 5mmx17cm coil (pc410051730/c27632) advanced halfway, but the coil could not advance.The surgeon removed and noted it stretched.The mc and coil were changed to complete the procedure.A constant and dedicated saline source was used at all time, and after the resistance was met, no additional force was used to further advance the device.There was no report on patient injury.No further information was received.The product was returned for analysis.Upon removal from the hoop dispenser it was found that the coil was not attached to the device positioning unit (dpu).The coil was mechanically detached from the dpu.The circumstances of how and when the coil was mechanically detached from the dpu cannot be determined.The stretched coil was found protruding outside the severed end of the microcatheter.A small proximal length of the stretched coil which all that remained was removed from the microcatheter.A guide wire was advanced through the microcatheter and no other section of the coil could be found.No issues were found with the severed microcatheter.The circumstances of how and when the microcatheter was severed with the coil inside cannot be determined.The distal tip of the coil containing the ball tip was not returned as was the stretch resistant suture.The circumstances of how and when the stretch resistance suture was severed and not returned cannot be determined.The distal section of the returned coil was severed and not returned.The fracture is ductile in nature requiring external force.No material defects were found.The circumstances of how and when the coil was severed and not returned cannot be determined.The proximal section of the return coil was unraveled out of the proximal soldered section.Approximately 23.5 centimeters of the microcatheter was severed and not returned.The circumstances of how and when the microcatheter was severed with the distal section of the coil (which was not returned) cannot be determined.No manufacturing defects were found.Due to severe damage and the missing sections found to both the coil and the microcatheter, the root cause of the coils strong resistance inside the microcatheter, its unintended mechanical detachment off the dpu, and its eventual stretching cannot be determined.In addition, without the return of the stretch resistant cerecyte suture, the distal section of the severed coil containing the ball tip, and the distal section of the returned 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.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

The product was received for analysis.

• 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: 4866706
• MDR Text Key: 22980155
• Report Number: 2954740-2015-00144
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2019
• Device Catalogue Number: PC410051730
• Device Lot Number: C27632
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 74