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

Catalog Number 637HF0308

Device Problems Difficult To Position (1467); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: concomitant medical devices included: prowler 14 microcatheter (catalog/lot unk and orbit coil (catalog 638mf0407/lot unk).It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Information regarding patient gender and weight were not available.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during coil embolization of a 4.1 x 2.5mm anterior communicating artery aneurysm, after placement of an orbit coil (638mf0407) via a prowler 14 microcatheter (catalog/lot unk), an orbit coil (637hf0308/15934926) wasn't positioned well.The surgeon adjusted the coil, and it stretched.The coil was removed still attached to the delivery wire, and was exchanged for a new coil to complete the procedure.The coil had not been entangled with the previously implanted coil and had not been left in the aneurysm during reposition the microcatheter.It was reported that a continuous flush had been maintained through the microcatheter.There was no report of patient injury.

Manufacturer Narrative

As reported by a healthcare professional, during coil embolization of a 4.1 x 2.5mm anterior communicating artery aneruysm, after placement of an orbit coil (638mf0407/15934926) via a prowler 14 microcatheter (catalog/lot unk), an orbit coil (637hf0308/15934926) wasn¿t positioned well.The surgeon adjusted the coil, and it stretched.The coil was removed still attached to the delivery wire, and was exchanged for a new coil to complete the procedure.The coil had not been entangled with the previously implanted coil and had not been left in the aneurysm during reposition the microcatheter.It was reported that a continuous flush had been maintained through the microcatheter.There was no report of patient injury.The device was returned for analysis.A non-sterile orbit helical fill 3x8 was received coiled inside of a plastic bag.No damages were noted on the hub.The hypotube was inspected and it was found kinked.The introducer was received unzipped and it was found without damage.The support coil, gripper and embolic coil were received outside of the introducer.The support coil was found without any damage.The gripper was inspected was found without damage while the embolic coil was found stretched.The gripper and embolic coil were inspected under microscope; the gripper was found without damage while the embolic coil was found stretched.Review of dhr for lot 15934926 concluded there were no issues that were considered potentially related to the reported complaint.The coil positioning difficulty could not be evaluated based on the nature of the complaint, but the coil stretch was confirmed during analysis.The condition of the embolic coil was apparently caused by applying excessive force on it, but it could not be conclusively determined.Inspections are in place that prevents this kind of failure leaving from the manufacturing facility.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process; therefore, no corrective action will be taken at this time.Udi: ((b)(4).

Manufacturer Narrative

The device was returned for analysis on 10/7/2015; however, the analysis has not yet been completed.Review of dhr for lot 15934926 concluded there were no issues that were considered potentially related to the reported complaint.(b)(4).Additional information will be submitted within 30 days of receipt.

• 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: kimberly soter ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 5134114
• MDR Text Key: 27838186
• Report Number: 1058196-2015-00184
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/16/2015

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: 06/30/2015
• Device Catalogue Number: 637HF0308
• Device Lot Number: 15934926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR