MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 014; WIRE, GUIDE, CATHETER

Catalog Number	M001468050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the subject guidewire was rotated in order to advance the guidewire into the microcatheter; however, resistance was encountered.The physician removed the guidewire from the patient and observed that approximately 50 cm of the proximal section of the guidewire was broken.The physician was able to retrieve the tip of the guidewire with the microcatheter and the procedure was completed successfully with no patient impact.
Additional Manufacturer Narrative
Expiration date: added.Manufacturing date: added.The device history review confirms that there was no indication that the device, labeling or manufacturing failed to meet its specifications when released.Visual inspection of the subject device discovered two broken fragments: the proximal part and distal part that remained to be loaded in the microcatheter that was full of blood.The guidewire was found bend along its length.Magnified examination of the fracture site revealed that the core wire was bent first and then separated.The functional test could not be performed because of the condition of the returned product.Additional information stated that there was an intermittent flush used during the procedure and there were cautions specified against it per the microcatheter¿s direction for use (dfu): ¿in order to achieve optimal performance of stryker neurovascular microcatheters and to maintain the lubricity of the hydrolene coating surface, it is critical that a continuous flow of appropriate flush solution be maintained between the stryker neurovascular microcatheter and guide catheter, and the microcatheter and any intraluminal device.In addition, flushing aids in preventing contrast crystal formation and/or clotting on both the intraluminal device and inside the guide catheter and/or the microcatheter lumen." it was also indicated that the guidewire was advanced against friction and that the caution against it was specified in the subject device dfu: "never advance the guidewire against excessive resistance without first determining the reason for resistance under fluoroscopy.Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter and/or vessel perforation".Therefore, because continues flush was not maintained the device performance became limited, that resulted in the reported friction, which likely to have contributed to the torsion against resistance, causing the kink and fracture of the guidewire.Based on the guidewire and related complaint microcatheter dfus, specifically cautioning about force against resistance and continuous flush maintenance to achieve optimum performance, the cause use error was assigned to the event.
Event or Problem Description
It was reported that during the procedure the subject guidewire was rotated in order to advance the guidewire into the microcatheter; however, resistance was encountered.The physician removed the guidewire from the patient and observed that approximately 50 cm of the proximal section of the guidewire was broken.The physician was able to retrieve the tip of the guidewire with the microcatheter and the procedure was completed successfully with no patient impact.

• Brand Name: TRANSEND EX 014
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101
• MDR Report Key: 5820941
• Report Number: 3004859241-2016-00007
• Device Sequence Number: 10813154
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: (01)08714729187332(17)170917(10)18419673
• Combination Product (Y/N): N
• PMA/510(K) Number: K934122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

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: 09/17/2017
• Device Catalogue Number: M001468050
• Device Lot Number: 18419673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2016
• Supplement Report FDA Received Date: 09/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR