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

Catalog Number 640CX0306

Device Problems Stretched (1601); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

The product will be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.Concomitant medical products and therapy dates: syringe ii (635-002/96331244), presidio 4x11.5 (details unknown), target 3.5mm coil (details unknown), excelsior sl-10 stryker microcatheter (details unknown), sheath introducer by terumo (model unknown), a ((b)(4), 0.014¿), an optimo ((b)(4), 8fr), a ¿(b)(4)¿ balloon catheter (manufacturer unknown), and a y-connector by goodman (model unknown) - details unknown.

Event Description

It was reported by the hospital contact that the shape of the proximal end (tail) of the complaint orbit galaxy (640cx0306/17011665) was strange and was unraveled at 7mm from the tail.After framing the target aneurysm with a presidio 4x11.5 (details unknown), the physician attempted to implant a target 3.5mm coil (details unknown).But the excelsior sl-10 stryker microcatheter (details unknown) got migrated out from the aneurysm, thus using the target was aborted and the microcatheter had to be re-positioned into the aneurysm.The complaint orbit galaxy was then inserted instead.Although there was no issue with the maneauvability of the embolic coil, during the insertion the physician identified that shape of the proximal end (tail) of the embolic coil was strange.The galaxy was withdrawn from the patient without an issue and it was discovered that the embolic coil seemed to be unraveled at 7mm from the tail.Therefore, the aforementioned target coil was re-used instead, which was successfully implanted this time.The procedure was completed without further issues or delay.There were no patient injury/complications.Initially, the physician requested the complaint dcs syringe ii (635-002/96331244) to be also analysed.However, the syringe has already been disposed, and only the galaxy will be available for analysis.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 further information is available.The procedure was the coil embolization of an unruptured aneurysm at the ic-pc.The patient was a (b)(6) year-old female whose vessels were moderately torturous but not calcified.A sheath introducer by terumo (model unknown), a ((b)(4), 0.014"), an optimo ((b)(4", 8fr), a " (b)(4)" balloon catheter (manufacturer unknown), and a y-connector by goodman (model unknown) were used in this procedure.

Manufacturer Narrative

It was reported by the hospital contact that the shape of the proximal end (tail) of the complaint orbit galaxy (640cx0306/17011665) was strange and was unraveled at 7mm from the tail.After framing the target aneurysm with a presidio 4x11.5 (details unknown), the physician attempted to implant a target 3.5mm coil (details unknown).But the excelsior sl-10 stryker microcatheter (details unknown) got migrated out from the aneurysm, thus using the target was aborted and the microcatheter had to be re-positioned into the aneurysm.The complaint orbit galaxy was then inserted instead.Although there was no issue with the maneuverability of the embolic coil, during the insertion the physician identified that shape of the proximal end (tail) of the embolic coil was strange.The galaxy was withdrawn from the patient without an issue and it was discovered that the embolic coil seemed to be unraveled at 7mm from the tail.Therefore, the aforementioned target coil was re-used instead, which was successfully implanted this time.The procedure was completed without further issues or delay.There were no patient injury/complications.Initially, the physician requested the complaint dcs syringe ii (635-002/96331244) to be also analysed.However, the syringe has already been disposed, and only the galaxy will be available for analysis.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 further information is available.The procedure was the coil embolization of an unruptured aneurysm at the ic-pc.The patient was a 68 year-old female whose vessels were moderately torturous but not calcified.A sheath introducer by terumo (model unknown), a chikai (asahi intecc, 0.014¿), an optimo (tokai medical products, 8fr), a ¿shoryu¿ balloon catheter (manufacturer unknown), and a y-connector by goodman (model unknown) were used in this procedure.A non-sterile og cmplx xtrasoft coil 3x6 was received coiled inside of a plastic bag.No damages were noted on the hub.The hypotube was inspected and it was found without any damage.The introducer was received zipped and it was found without damage.The support coil, gripper and embolic coil were received inside of the introducer.The support coil was inspected and it was found without any damage.The gripper was inspected and no damages were noted.However; residues of dry blood were found on it.The embolic coil was found stretched and bent.The suture was found intact without breakage.The gripper and embolic coil were inspected under microscope; the gripper was found without damage.However; residues of dry blood were found on it.The embolic coil was found stretched and bent.The suture was found intact without breakage.The failure reported by the customer as ¿coil- out of shape¿ could not be evaluated due to condition of the embolic coil stretched and bent.The failure reported by the customer as ¿coil- unraveled/stretched¿ was confirmed during the microscope analysis.The condition of the embolic coil was apparently caused by applying excessive force on it but it could not be conclusively determined.However these defects could not be related to the manufacturing process and procedural factors appear to have contributed to have these damages.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally inspections are in place that prevents this kind of failures leaving from the facility.Therefore no corrective action 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 ; 325 paramount dr; raynham, MA 02767 ; 5089777396
• MDR Report Key: 4993511
• MDR Text Key: 25484206
• Report Number: 1226348-2015-00017
• 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,foreig
• Reporter Occupation: Other
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 640CX0306
• Device Lot Number: 17011665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR