MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) HYDRA JAGWIRE¿; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M00556041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned guidewire revealed that the core wire of the hydrajagwire was broken and the coating ptfe was peeled (both failures were found in the same section).The complaint was not consistent with the reported event that the distal tip was detached.It is the most likely that the failure found could have been generated due to anatomical/procedural factors, moreover, the outer diameter of the device was found within specification, therefore the most probable root cause of this complaint is operational context.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a hydra jagwire¿ guidewire was used during a procedure performed on (b)(6) 2017.According to the complaint, during the procedure, the coating of the guidewire tip came off.The procedure was completed with a new hydra jagwire¿ guidewire.There were no patient complications reported as a result of this event.The patient¿s condition at the conclusion of the procedure was reported to be no patient injury.Investigation results revealed on june 9, 2017 that the core wire is broken.

• Brand Name: HYDRA JAGWIRE¿
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6672712
• Report Number: 3005099803-2017-01871
• Device Sequence Number: 10783486
• Product Code: EZB
• UDI-Device Identifier: 08714729648475
• UDI-Public: (01)08714729648475(17)20200119(10)0020184503
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2017

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: 01/19/2020
• Device Model Number: M00556041
• Device Catalogue Number: 5604
• Device Lot Number: 0020184503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1