MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ORBIT GALAXY DETACHABLE COIL SYSTEM; ARTIFICIAL EMBOLIZATION DEVICE

Catalog Number 640CR1030

Device Problem Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2013

Event Type  malfunction  

Event Description

(b)(6) 2013: received a call from customer from the university of chicago.He stated that there were 3 defective devices.The codes are below: 606-151fx (15956301), 640cr1030 (15842720), dmx181040-20 (c11840).(b)(6) 2014: the prowler 14 (606-151fx/15956301) was advanced into the aneurysm.The deltamaxx 10x40 coil (dmx181040-20/c11840) was then introduced into the prowler 14.The coil advanced to within 10cm of the end of the microcatheter and would not go any further.The deltamaxx coil was removed and the galaxy frame 10x30 (640cr1030/15842720) was introduced into the microcatheter.It was advanced to within 10cm of the end of the microcatheter at which point it too met resistance.The entire system (prowler 14 and galaxy frame coil) was removed and a second prowler 14 was placed into the aneurysm.A second galaxy frame 10x30 was then advanced into the aneurysm without incident.Subsequent coils were introduced through the second prowler microcatheter and the aneurysm was well treated.There were no adverse events associated with this incident.There were no damages noted on any of the devices after use.An adequate continuous flush was maintained through the microcatheter.The target vessel was ica which was not calcified and mildly tortuous.

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 15842720 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The product was received for analysis, but it has not been completed.Additional information will be submitted within 30 days of receipt.Concomitant medical products and therapy dates: prowler 14 (606-151fx/15956301), deltamaxx 10x40 coil (dmx181040-20/c11840), second prowler 14 (details unknown), second galaxy frame 10x30 (details unknown), subsequent coils (details unknown).

Manufacturer Narrative

It was initially reported that there were three defective devices including prowler 14 (606-151fx/15956301), deltamaxx 10x40 coil (dmx181040-20/c11840), and a galaxy frame 10x30 (640cr1030/15842720).With additional follow-up information it was determined that during treatment of an internal carotid artery (ica) there was resistance with both coils during insertion into the prowler 14; the deltamaxx was removed from the prowler 14 and exchanged for a galaxy which was then removed as a unit along with the prowler 14 after the event.There were no adverse events associated with this incident.The prowler 14 (606-151fx/15956301) was advanced into the aneurysm.The deltamaxx 10x40 coil (dmx181040-20/c11840) was then introduced into the prowler 14.The coil advanced to within 10cm of the end of the microcatheter and would not go any further.The deltamaxx coil was removed and the galaxy frame 10x30 (640cr1030/15842720) was introduced into the microcatheter.It was advanced to within 10cm of the end of the microcatheter at which point it too met resistance.The entire system (prowler 14 and galaxy frame coil) was removed and a second prowler 14 was placed into the aneurysm.A second galaxy frame 10x30 was then advanced into the aneurysm without incident.Subsequent coils were introduced through the second prowler microcatheter and the aneurysm was well treated.There were no damages noted on any of the devices after use.An adequate continuous flush was maintained through the microcatheter.The target vessel was ica which was not calcified and mildly tortuous.The deltamaxx coil system is not available for analysis.A non-sterile orbit galaxy tight distal loop complex frame coil 10 x 30 was received coiled inside of a plastic bag.The hypotube was inspected and it was found kinked.The introducer was received unzipped and it was found kinked.The support coil, gripper and the embolic coil were received outside of the introducer and no damages were noted on it.The gripper and embolic coil were inspected under microscope and no damages were noted on the.The introducer was found kinked.The od from the delivery tube was measured and was found within specification.Full functional testing could not be performed with the returned device due to the kinked damages of the introducer.The timing of the damage cannot be determined; however, it is possible that it was related to the procedural/post procedural handling for return.Although full functional testing could not be completed with the returned galaxy system, the id was within specification.Additionally, with analysis of the returned microcatheter finding obstruction due to compressed sections along the distal end and with residuals of blood, it appears that factors impacting the concomitant device may have contributed to the event.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Additionally inspections are in place to prevent devices with this type of failure from leaving the facility.Therefore, no corrective actions will be taken at this time.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3585091
• MDR Text Key: 20269756
• Report Number: 1226348-2014-10002
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/27/2013

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: 640CR1030
• Device Lot Number: 15842720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1