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

Catalog Number 640CF0925

Device Problems Difficult To Position (1467); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2015

Event Type  malfunction  

Event Description

During emergency arterial embolization to treat an abdominal bleed, it was reported that the orbit galaxy (640cf0925 / 17095112) became unraveled while placing the coil into the target lesion site.According to the physician, the embolic coil had not looped, and he had difficulty placing the coil into the target site.The orbit galaxy was safely removed from the patient and another galaxy (7x21, lot unknown) was inserted instead, with which the embolization was successful.The procedure was completed without further issues or delay.There were no patient injuries or complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the instructions for use (ifu) and the constant flush had been maintained through the non-codman microcatheter at all times.There was no unintended detachment of the coils observed in the microcatheter.No visible damage was noted on the product prior to the event.There was no report of coil entanglement, resistance within the microcatheter during advancement, kinks on the microcatheter or repositioning of the microcatheter during coil positioning.Details of the exact position of the embolic coil when the unraveling occurred was unavailable.The procedure was completed with the same microcatheter.Since the patient was an hcv carrier, the complaint product was discarded.The patient¿s vessels were heavily tortuous.No further information was available.

Manufacturer Narrative

Concomitant medical products: a chikai (asahi intecc), a headway (terumo, type unknown), an okay ii (goodman), and an enpower dcb / cable (lots unknown) were used for this procedure.Information regarding patient age and weight were not provided.Complaint conclusion: the device was not returned for analysis.Review of the dhr for lot 17095112 concluded that one unit was rejected for coil kink and may be related to the reported complaint.However, the dhr review confirmed that the rejected unit was properly segregated and discarded.Controls are in place to detect such non-conformities.No other issues were noted that were considered potentially related to the reported complaint.The coil unraveling and coil positioning difficulty could not be confirmed without product return for analysis, and the root cause of the event could not be determined; however, procedural factors may have contributed to the event.Products are inspected prior to being released from the manufacturing facility to identify these types of failures.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.This is an initial/final mdr.

• 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: duane durbin ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288310
• MDR Report Key: 4852699
• MDR Text Key: 5806239
• Report Number: 3008264254-2015-00036
• Device Sequence Number: 1
• Product Code: HCG
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/28/2015

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: 08/31/2016
• Device Catalogue Number: 640CF0925
• Device Lot Number: 17095112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1