MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC NEUROSCOUT GUIDEWIRES; WIRE, GUIDE, CATHETER, NEUROVASCULAR

Catalog Number	601414
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mof/dqx.It is anticipated that the device will be returned for analysis; however, the device has not yet been received.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during cerebral coil embolization, as the neuroscout guidewire (601414/ h28087) was handed to the specialist, it was noted that it had ¿strands out¿, and therefore, the device was not used in the patient.The device had been stored as per labelling instructions.There was no procedure delay.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
It was reported that the device would be returned for analysis; however, after multiple attempts, no additional information could be obtained and the device was not returned for analysis.Conclusion: as reported by a healthcare professional, during cerebral coil embolization, as the neuroscout guidewire (601414/ h28087) was handed to the specialist, it was noted that it had ¿strands out¿, and therefore, the device was not used in the patient.The device had been stored as per labeling instructions.There was no procedure delay.It was reported that the device would be returned for analysis; however, the device was not returned and multiple attempts to obtain additional information were unsuccessful.The device was not returned for analysis.The dhr review of the manufacturing documentation associated with this lot h28087 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The damage to the guidewire could not be confirmed without product return for analysis.Based on the minimal information that could be obtained, the root cause could not be determined.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 events were related to a manufacturing issue, no corrective actions will be taken at this time.
Additional Manufacturer Narrative
Conclusion: updated with product analysis: as reported by a healthcare professional, during cerebral coil embolization, as the neuroscout guidewire (601414/ h28087) was handed to the specialist, it was noted that it had ¿strands out¿, and therefore, the device was not used in the patient.The device had been stored as per labelling instructions.There was no procedure delay.It was reported that the device would be returned for analysis.The device was returned and examined under microscopy.The distal tip bound was not intact, through remnants of the adhesive could be visualized.The distal bead had been placed into a "j" shape with the very distal portion showing a bend.The mid joint and proximal bonds are intact.The diameter meets the 0.014" specification except at the very tip.The tip bound passed multiple inspection and proof loading.The tip shape and adhesive remnant strongly suggest that the bound failed during tip shaping process, which is performed by the user.The "strands out" condition can be attributed to user error.The dhr review of the manufacturing documentation associated with this lot h28087 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The event was confirmed based on the condition of the returned device.The root cause of the event appears to have been related to the user re-shaping the distal tip.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: NEUROSCOUT GUIDEWIRES
• Common Device Name: WIRE, GUIDE, CATHETER, NEUROVASCULAR
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6646549
• Report Number: 1226348-2017-00074
• Device Sequence Number: 11084171
• Product Code: DQX
• UDI-Device Identifier: 10886704028390
• UDI-Public: (01)10886704028390(17)181231(10)H28087
• Combination Product (Y/N): N
• PMA/510(K) Number: K100351
• 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
• Report Date (Section B): 05/22/2017

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: 12/31/2018
• Device Catalogue Number: 601414
• Device Lot Number: H28087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 07/19/2017; 10/16/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 07/20/2017; 11/08/2017
• Patient Sequence Number: 1