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); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

The contact at the facility reported that during coil embolization of a 4mm aneurysm at the distal anterior cerebral artery a piece of the embolic coil, an orbit galaxy (640cx0304 / 16083582) was present at the microcatheter (mc) marker prior to detachment.The patient was a female of unknown dob, whose vessels were moderately tortuous but the calcification level was unknown.A 7fr/25cm sheath introducer by unspecified manufacturer, a transend (stryker, 0.014¿ / 200cm), a roadmaster (goodman, 7fr), an excelsior sl-10 (stryker), and a dcs syringe ii (lot unknown) were used in this procedure.The complaint galaxy was used as the framing coil.After looping the embolic coil inside the aneurysm, the physician was about to detach the coil, but realized that the mc marker was not aligned with the delivery tube marker but with unidentified object.Since the embolic coil was completely looped inside the aneurysm, the physician was unsure of what was aligned with the mc marker.The galaxy was recovered from the patient for safety precaution, and the unidentified object was in fact the proximal end of the embolic coil where it may have unraveled/stretched.Upon removing the coil, it was noted that the coil was stretched.The microcatheter remained in place while the coil was withdrawn.The procedure was completed without further issues or delay.There were no patient injury/complications.The complaint product was new and stored per labeling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 coils observed in the mc or in the vessel.There was no resistance/friction when advancing the coil through the microcatheter or advancing the microcatheter over a guidewire.The complained product will be returned for analysis.No further information is available.

Manufacturer Narrative

The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.

Manufacturer Narrative

A non-sterile og cmplx xtrasoft coil 3x4 was received inside coiled of a plastic bag.The hypotube was inspected and it was found kinked.The introducer was received un-zipped and it was found without damage.The support coil, gripper and embolic coil were received outside of introducer.The support coil was inspected and it was found without damage, the gripper was found without damage.The embolic coil was found stretched.The suture was found intact without breakage.The gripper and embolic coil were inspected under microscope; the gripper was found without damage, residues of dry blood were noted on it.The embolic coil was found stretched.The suture was found intact without breakage.The review of lot 16083582 revealed no anomalies that were considered potentially related to the reported complaint.The failure reported by the customer that the coil could not be positioned properly could not be evaluated as exact procedural conditions cannot be duplicated.The failure reported by the customer that the coil stretched was confirmed during the analysis.The cause of the failure experienced by the customer and the damages found on the device could not be conclusively determined; however neither the analysis nor the dhr suggest that it could be related to the manufacturing process; additionally inspections are in place that prevent these kinds of damages leaving from the facility.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: duane durbin ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288310
• MDR Report Key: 4835407
• MDR Text Key: 18032283
• Report Number: 3008264254-2015-00035
• 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: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2015

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: 02/28/2016
• Device Model Number: N/A
• Device Catalogue Number: 640CX0304
• Device Lot Number: 16083582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 06/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1