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

Catalog Number	640CF0412
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: krd/hcg.Conclusion: the galaxy coils were not returned for analysis.Review of dhr for lot 17551492 concluded there were no issues that were considered potentially related to the reported complaint.The resistance between the galaxy coils and the prowler 14 microcatheter could not be confirmed without product return for analysis.The root cause of the event could not be determined based on the information received.There was no evidence to suggest the events were related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is 1 of 4 mdr reports being submitted for this complaint, with associated report numbers of 3008264254-2017-00015, 3008264254-2017-00014, 3008264254-2017-00022 and 3008264254-2017-00021.Corrected data: the initial information for this compliant was submitted in mdr report number 3008264254-2017-00015 on 2/6/2017.There were 2 devices with the same malfunction and same catalog and lot numbers.Both of those devices were reported on mdr 3008264254-2017-00014.This mdr is being sent as a correction to separate the devices into separate mdr reports, and to submit the complaint conclusion.
Event or Problem Description
It was reported by a healthcare professional that during a coiling procedure of a pcom aneurysm, the physician was unable to push two 4 x 12 galaxy coils (640cf0412/175514192) into two prowler 14 microcatheters (606151fx/17669016), and the coils and catheters were replaced.The physician was unable to advance the galaxy delivery system and experienced a lot of friction during withdrawal.The coil was contained inside of the sheath as the physician had not yet advanced it.With some force, the physician was able to pull the galaxy coil out of the prowler 14 microcatheter.The physician discarded both the galaxy coil and the prowler 14 microcatheter and began the process again with the second galaxy coil 4x12 and prowler 14 microcatheter.The same issue happened again; the coil would not advance as the physician said it became stuck in the microcatheter and they had trouble pulling it back out.The physician discarded the second galaxy coil 4x12 and prowler 14 microcatheter and completed the procedure with a third prowler 14 microcatheter and galaxy 3.5x9 coil.The difficulty occurred at the distal part of the body of the catheter; the galaxy coils were able to be advanced to the distal portion of the microcatheter.The galaxy coils and prowler 14 microcatheters were removed together as a unit from the patient as the coil was stuck inside the microcatheter.An adequate continuous flush was maintained through the catheters.The procedure was delayed 10 minutes since had to struggle to remove the devices.No medical intervention was required.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6366516
• Report Number: 3008264254-2017-00022
• Device Sequence Number: 648285
• Product Code: HCG
• UDI-Device Identifier: 10886704030270
• UDI-Public: (01)10886704030270(17)180731(10)17551492
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 640CF0412
• Device Lot Number: 17551492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 02/28/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER 14 MICROCATHETER