MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUFILL DCS ORBIT MINI COMPLEX FILL; CNV DCS ORBIT (HCG)

Catalog Number 637MF3575

Device Problems Failure to Advance (2524); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2014

Event Type  malfunction  

Event Description

The surgeon put 6f gc (details unknown) and prowler 14 mc (details unknown) in place then decided to advance the orbit mini comp fill 3.5x7.5 (b)(4) but felt much resistance in the microcatheter.The coil was removed and it was noted that the blue symbol of the detachable coil delivery system cracked.The coil was removed together with the microcatheter.The surgeon had to change to same like coils (details unknown) to complete the surgery.The same microcatheter was used to complete the procedure.An adequate continuous flush was maintained through the microcatheter.The patient is fine now.There was no report on patient injury.There was no delay in the procedure due to the event.The patient had right middle cerebral artery aneurysm with size 4.2*3.2mm.The aneurysm diameter was 2.8mm without stenosis.Target access is femoralis.

Manufacturer Narrative

The product will be returned for analysis, but it has not been received to date.Additional information will be submitted within 30 days of receipt.Concomitant medical products and therapy dates: 6f gc (details unknown).Prowler 14 mc (details unknown).Same like coils (details unknown).This is 1 of 2 reports associated with complaint (b)(4).

Manufacturer Narrative

The dhr was reviewed and no anomalies were noted.The product was received for analysis, but it has not been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

The surgeon put 6f gc (details unknown) and prowler 14 mc (details unknown) in place then decided to advance the orbit mini comp fill 3.5x7.5 (637mf3575/15839961) but felt much resistance in the microcatheter.The coil was removed and it was noted that the blue symbol of the detachable coil delivery system cracked.The coil was removed together with the microcatheter.The surgeon had to change to same like coils (details unknown) to complete the surgery.The same microcatheter was used to complete the procedure.An adequate continuous flush was maintained through the microcatheter.The patient is fine now.There was no report on patient injury.There was no delay in the procedure due to the event.The patient had right middle cerebral artery aneurysm with size 4.2*3.2mm.The aneurysm diameter was 2.8mm without stenosis.Target access is femoralis.A non-sterile orbit mini comp fill 3.5x7.5 was received coiled inside of plastic bag.The hypotube was inspected and it was broken / separated in two pieces as well as kinks were noted on it.The introducer was received partially zipped and no damages were noted on it.The support coil and gripper without damage while the embolic coil was found stretched.The edges of the broken / separated section, the gripper and the embolic coil were inspected under microscope; the gripper was found without damage while the embolic coil was found stretched and the edges of the broken / separated section shows evidence that appears that the device was elongated before it was broken.The od from the delivery tube was measured and was found within specification.The functional test cannot be performed due to the device was received in two pieces.A review of the manufacturing documentation associated with this lot 15839961 presented no issues during the manufacturing process that can be related to the reported complaint.The failure reported by the customer as ¿dcs ¿ impeded¿ could not be evaluated due to the conditions of the received unit.The failure reported by the customer as ¿dcs ¿ damage¿ was confirmed due to the device was received separated in two pieces.However this condition appears was due to applying excessive on the device but it could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally inspections are in place that prevents this kind of failures from leaving the facility.Therefore no corrective action will be taken at this time.

• Brand Name: TRUFILL DCS ORBIT MINI COMPLEX FILL
• Type of Device: CNV DCS ORBIT (HCG)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4305988
• MDR Text Key: 5190177
• Report Number: 1058196-2014-00301
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K053197
• 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: 11/26/2014

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: 03/31/2015
• Device Catalogue Number: 637MF3575
• Device Lot Number: 15839961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 12/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/30/2014; 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2013
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 48