MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM; ARTIFICIAL EMBOLIZATION DEVICE

Catalog Number 641CX0202

Device Problems Difficult to Remove (1528); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2014

Event Type  malfunction  

Event Description

The initial report indicated that the coil does not slide properly from the packing hoop.However, additional information indicated that the procedure was coil embolization using a galaxy g2.The coil used was g2 xtrasoft 2 mm x2 cm (catalog no.641cx0202) through a prowler select plus 2.8f/2.3f straight microcatheter (catalog no.606s255x).Coil doesn¿t slide properly from the packing hoop and the physician decided to remove coil and had trouble pulling coil back into microcatheter.In the process the coil turned threadbare.The damage device (coil) was replace with a new coil with same like product.The product was stored per labeling instructions, and there were no damages noticed on the exterior or inner package that may have contributed to the event.After the event, damages was noticed on the device (frayed), but the coil remained attached to the delivery system.The vessel characteristic was normal.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

It was reported that when the coil was reinserted into the sheath, the coil lost the shape and it was frayed, and the device could never put the coil in the aneurysm or pass the coil through the microcatheter because from the beginning confronted problems to slide the coil out of the sheath.After the event, only the coil was removed, since the coil wasn¿t used or never passed through the microcatheter due to problems confronted.The target site was not lost due to the event, and a constant and dedicated saline source was used at all time through the microcatheter.The distal tip of the microcatheter was not reshaped, and the target site was the pcom aneurysm.The device was received for analysis.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

The initial report indicated that the coil does not slide properly from the packing hoop.However, additional information indicated that the procedure was coil embolization using a galaxy g2.The coil used was g2 xtrasoft 2 mm x2 cm (catalog no.641cx0202) through a prowler select plus 2.8f/2.3f straight microcatheter (catalog no.606s255x).Coil doesn¿t slide properly from the packing hoop and the physician decided to remove coil and had trouble pulling coil back into microcatheter.In the process the coil turned threadbare.The damage device (coil) was replaced with a new coil with same like product.The product was stored per labeling instructions, and there were no damages noticed on the exterior or inner package that may have contributed to the event.After the event, the device was damaged (frayed), but the coil remained attached to the delivery system.The vessel characteristic was normal.The device was not returned for analysis, although an unknown unit was received.The prowler select plus microcatheter and the rhv were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned/rinsed before being returned which may have produced further damage.It is also unknown if the device was further manipulated and/or inspected post-procedurally.Any trace evidence that may have been complaint related may have been altered or removed prior to being returned.As viewed into the returned packaging it was found that the coil was stretched and entangled.The coil was returned completely stretched and was found protruding outside the sheath from the distal tip of the skive.Due to post-procedural handling it cannot be determined how much coil damage occurred during the procedure.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been severely fractured with the damaged edges elevated above the surface plane.The locking mechanism has compression and stretching damage.No manufacturing defects were found.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 the reported event could was confirmed, but the cause could not be determined.Based on the information and analysis, the reported event could be related to procedural factors or handling.Additionally, 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.

Manufacturer Narrative

The initial report indicated that the coil does not slide properly from the packing hoop.However, additional information indicated that the procedure was coil embolization using a galaxy g2.The coil used was g2 xtrasoft 2 mm x2 cm (catalog no.641cx0202) through a prowler select plus 2.8f/2.3f straight microcatheter (catalog no.606s255x).Coil doesn¿t slide properly from the packing hoop and the physician decided to remove coil and had trouble pulling coil back into microcatheter.In the process the coil turned threadbare.The damage device (coil) was replaced with a new coil with same like product.The product was stored per labeling instructions, and there were no damages noticed on the exterior or inner package that may have contributed to the event.After the event, the device was damaged (frayed), but the coil remained attached to the delivery system.The vessel characteristic was normal.The device was not returned for analysis, although an unknown unit was received.It is confirmed that the wrong product was returned.Instead of a 641cx0202, lot c18949, an 640cx0202, orbit galaxy, lot 17065850 was returned in its original box.Therefore, the root cause of the coil not sliding out of the hoop, the difficulty of pulling the coil out of the microcatheter and its threadbare damage as reported cannot be determined.A review of the manufacturing documentation associated with this lot (c18949) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The device was not returned for analysis, and the event cannot be confirmed.With the information provided it is possible that procedure factors may have contributed to the event.Additionally, 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 taking at this time.

Manufacturer Narrative

(b)(4).The product was received for analysis.

• Brand Name: ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 4333500
• MDR Text Key: 5140305
• Report Number: 2954740-2014-50059
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K120686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2015

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: 06/22/2018
• Device Catalogue Number: 641CX0202
• Device Lot Number: C18949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2015
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/05/2015; 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1