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

Catalog Number	640CX2535
Medical Device Problem Codes	Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device would be returned for analysis; however, the device has not yet been returned for analysis.The dhr review of the manufacturing documentation associated with this lot 17449396 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, the physician pulled the orbit galaxy coil (640cx2535/ 17449396) and unspecified microcatheter at the same time and after inspection, the coil was found to be stretched.There were no potential adverse events.
Additional Manufacturer Narrative
As reported by a healthcare professional, during coil embolization of the middle cerebral artery, the physician pulled the orbit galaxy coil (640cx2535/17449396) and prowler select lpes microcatheter at the same time and after inspection, the coil was found to be stretched.The microcatheter was removed due to a device handling issue not related to a product malfunction.There was no resistance during advancement or withdrawal of the coil from the microcatheter.A continuous flush had been maintained through the microcatheter.The coil had not exited the microcatheter into the patient.When the coil was removed, it was still attached to the delivery tube.The event did not result in a procedure delay.There were no potential adverse events.A non-sterile orbit galaxy cmplx xtrasoft coil 2.5x3.5 was received coiled inside of a pouch.The hypotube was inspected and no damages were noted on it.The introducer was found unzipped.The support coil was found outside of the introducer.The gripper and the embolic coil were found in tangled condition with the device.The gripper and embolic coil were inspected under microscope; no damages were noted on the gripper while the embolic coil was found stretched as well as the suture was found broken.The edges of the broken section of the suture show evidence that appear that it was elongated before it was broken.The od from the delivery tube was measured and was found within specification.The functional analysis cannot be performed due to the embolic coil was found stretched.The dhr review of the manufacturing documentation associated with this lot 17449396 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The coil stretch was confirmed.The cause of the stretched/broken condition noted on the embolic coil was apparently caused by applying excessive force on the device but it could not be conclusively determined.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 failure from leaving the facility.Procedural factors may have contributed to this condition.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.
Additional Manufacturer Narrative
Additional information was received on 18 oct 2017: the procedure was coiling of the middle cerebral artery.The microcatheter used was a select lp es.The microcatheter was removed due to a device handling issue not related to a product malfunction.There was no resistance during advancement or withdrawal of the coil from the microcatheter.A continuous flush had been maintained through the microcatheter.The coil had not exited the microcatheter into the patient.When the coil was removed, it was still attached to the delivery tube.The event did not result in a procedure delay.It was reported that the device would be returned for analysis; however, after multiple attempts to have the product returned, it was not returned.Conclusion: as reported by a healthcare professional, during coiling of the middle cerebral artery, the physician pulled the orbit galaxy coil (640cx2535/ 17449396) and select lp es microcatheter at the same time and after inspection, the coil was found to be stretched.It was reported that the microcatheter was removed due to a device handling issue, not related to a product malfunction, and there was no resistance during advancement or withdrawal of the coil from the microcatheter.A continuous flush had been maintained through the microcatheter.The coil had not exited the microcatheter into the patient.When the coil was removed, it was still attached to the delivery tube.The event did not result in a procedure delay.There were no potential adverse events.A photo was received for an orbit galaxy cmplx xtrasoft coil 2.5x3.5; in this image the embolic coil was found stretched in tangled condition with the hypo tube.No other damages were observed in the device picture.The dhr review of the manufacturing documentation associated with this lot 17449396 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The coil stretch was confirmed based on visual analysis of the photo received.The stretched condition noted on the coil was apparently caused by applying excessive force on the device, but it could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported by the costumer could be related to the manufacturing process.Procedural factors and handling process may contribute to the failure as reported.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: XTRASOFT ORBIT GALAXY DETACHABLE COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6950759
• Report Number: 3008264254-2017-00139
• Device Sequence Number: 1460443
• Product Code: HCG
• UDI-Device Identifier: 10886704030676
• UDI-Public: (01)10886704030676(17)180228(10)17449396
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 640CX2535
• Device Lot Number: 17449396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 01/01/2017; 10/18/2017; 11/13/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 10/17/2017; 11/01/2017; 12/08/2017
• Patient Sequence Number: 1