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

Catalog Number 640HX0203

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: a guide wire (silverspeed 10, covidien (b)(4)) and a micro catheter (sl10, stryker) were also used for this procedure.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during coil embolization of an unruptured 7mm basilar artery aneurysm, an orbit galaxy coil (640hx0204/ 17337449) kicked back during placement and could not be rezipped, and another orbit galaxy coil (640hx0203/ 17341874) came out of the lesion and could not be rezipped.The first coil (lot 17337449) was inserted, but the coil was kicked back and could not be placed in the lesion, so the physician tried to re-sheath the coil, but the zipper got stuck and could not be re-sheathed.The coil was replaced with another one and the procedure was continued.The second coil (lot 17341874) was inserted, but the coil was out of the lesion and the physician tried to re-sheath the coil, but the same issue reoccurred with the coil.The coil was replaced with another one (galaxy).An sl 10 microcatheter was used for the procedure.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The devices are not available for investigation.No further information was available.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during coil embolization of an unruptured 7mm basilar artery aneurysm, an orbit galaxy coil (640hx0204/ 17337449) kicked back during placement and could not be rezipped, and another orbit galaxy coil (640hx0203/ 17341874) came out of the lesion and could not be rezipped.The first coil (lot 17337449) was inserted, but the coil was kicked back and could not be placed in the lesion, so the physician tried to re-sheath the coil, but the zipper got stuck and could not be re-sheathed.The coil was replaced with another one and the procedure was continued.The second coil (lot 17341874) was inserted, but the coil was out of the lesion and the physician tried to re-sheath the coil, but the same issue reoccurred with the coil.The coil was replaced with another one (galaxy).An sl 10 microcatheter was used for the procedure.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and a constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The devices are not available for investigation.No further information was available.A review of the manufacturing documentation associated these lots presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The positioning difficulty, re-sheathing difficulty (both devices) and coil herniation from the aneurysm (lot 17341874) could not be confirmed without product return.The root cause of the issue could not be determined; however, the concomitant non-codman microcatheter may have contributed to the event.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the devices.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: XTRASOFT ORBIT GALAXY DETACHABLE COIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 6885868
• MDR Text Key: 87863935
• Report Number: 3008264254-2017-00129
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704069614
• UDI-Public: (01)10886704069614(17)170831(10)17341874
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093973
• 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: Initial,Followup
• Report Date: 08/29/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 640HX0203
• Device Lot Number: 17341874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 10/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1