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

Catalog Number 640CR1230

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: prowler lpes microcatheter (606-s155fx/17259727).Information regarding patient age, gender, and weight are not available.(b)(4).The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdr reports being submitted for this complaint with associated report numbers of 3008264254-2015-00071 and 3008264254-2015-00070.

Event Description

As reported via a healthcare professional, during coil embolization of a right internal carotid artery cavernous segment aneurysm, an orbit galaxy coil (640cr1230/16054124) pushed the prowler lpes microcatheter (606-s155fx/17259727) out of the aneurysm due to coil positioning difficulty and difficulty in getting the coil to conform to the aneurysm wall, and the coil was not able to be deployed.There was no coil protrusion from the aneurysm or reduced blood flow due to the coil positioning difficulty, and no resistance between the coil and microcatheter or need to withdraw the microcatheter with the coil.Another orbit galaxy coil (640cr1230/16054124) hypotube "bent" while being loaded into the microcatheter, and when the doctor tried to straighten out the kink by applying force, it "snapped".The coil had not exited the microcatheter and was removed from the microcatheter.The same microcatheter was used to implant all 48 coils implanted during the procedure.There had been no resistance between the coils and microcatheter and no damage to the actual coil.It was reported that the devices had been used and prepped as per the instructions for use (ifu), and had appeared normal prior to use.The events did not result in patient injury or clinically significant delay in the procedure.

Manufacturer Narrative

Complaint conclusion: as reported via a healthcare professional, during coil embolization of a right internal carotid artery cavernous segment aneurysm.An orbit galaxy coil (640cr1230/16054124) pushed the prowler lpes microcatheter (606-s155fx/17259727) out of the aneurysm due to coil positioning difficulty and difficulty in getting the coil to conform to the aneurysm wall, and the coil was not able to be deployed.There was no coil protrusion from the aneurysm or reduced blood flow due to the coil positioning difficulty, and no resistance between the coil and microcatheter or need to withdraw the microcatheter with the coil.Another orbit galaxy coil (640cr1230/16054124) hypotube "bent" while being loaded into the microcatheter, and when the doctor tried to straighten out the kink by applying force, it "snapped".The coil had not existed the microcatheter and was removed from the microcatheter.The same microcatheter was used to implant all 48 coils implanted during the procedure.There had been no resistance between the coils and microcatheter and no damage to the actual coil.It was reported that the devices had been used and prepped as per the instructions for use (ifu), and had appeared normal prior to use.The events did not result in pt injury or clinically significant delay in the procedure.A non-sterile orbit galaxy tdl cmplx frame coil 12x30 was received, coiled inside of a plastic bag.The hypotube was inspected and no damages were noted on it.The introducer was found partially unzipped without damage.Part of the support coil was found outside of the introducer from the proximal end; the rest of it the gripper and the embolic coil were found inside of the introducer.The gripper and the embolic coil were inspected under microscope through of the introducer.The embolic coil was found stretched and no damages were noted on the gripper, as well as residues of dry blood can be observed on inside of the introducer.A review of the mfg documentation associated with this lot 16054124 presented no issues during the mfg process that can be related to the reported complaint.The coil positioning difficulty could not be evaluated based on the nature of the event, and the root cause of the event could not be determined.The coil stretching found during analysis most likely occurred during post-procedural handling/shipping since it was reported that the coil was not damaged during the procedure.The inadequate support of the microcatheter could not be confirmed without return for analysis and the root cause could not be confirmed; however, procedural factors appear to have contributed to the event.Since there was no evidence of a mfg issue related to the event, no corrective actions will be taken at this time.This is 1 of 2 mdr reports being submitted for this complaint with associated report numbers of 3008264254-2015-00071 and 00070.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288310
• MDR Report Key: 5207399
• MDR Text Key: 30602925
• Report Number: 3008264254-2015-00070
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: 640CR1230
• Device Lot Number: 16054124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1