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

Model Number N/A

Device Problems Difficult To Position (1467); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

The product will not be returned for analysis; however, a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.

Event Description

The contact at the hospital reported that the orbit galaxy coil (640cx0304 / 17046196) did not conform to the aneurysm walls and could not be re-sheathed.The procedure was the coil embolization of an aneurysm at the middle cerebral artery.The patient's vessels were mildly tortuous and mildly calcified.No information of the concomitant devices used in this procedure was available.Although the complaint galaxy was delivered into the target aneurysm, the embolic coil did not loop inside the aneurysm as the physician wished.Therefore, the physician attempted to recover the galaxy from the patient.However, the zipper was too stiff to re-sheath the coil.The physician concluded that the galaxy cannot be re-sheathed and withdrew the galaxy un-sheathed.The procedure was completed without further issues or delay.There were no patient injury/complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.No visible damage was noted on the product prior to the event.There was no unintended detachment of the coil observed in the vessel or in the microcatheter.The complained product has already been disposed.No further information is available.

Manufacturer Narrative

Review of dhr for lot 17046196 revealed no anomalies that can be related to the reported complaint.Based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.

• Brand Name: XTRASOFT ORBIT GALAXY DETACHABLE COIL
• 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 ; 5089777396
• MDR Report Key: 5046956
• MDR Text Key: 24790064
• Report Number: 3008264254-2015-00060
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Health Professional
• Report Date: 08/11/2015

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: 05/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 640CX0408
• Device Lot Number: 17046196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2015
• Date Device Manufactured: 07/04/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1