MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) AMPLATZ SUPER STIFF¿; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066401091
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was reported to the fda via a voluntary medwatch report.(b)(4).Visual examination of the returned guidewire revealed that the coil wire was kinked and elongated.In addition, the core wire was broken at 1.9 cm from the distal tip the complaint is consistent with the reported event that the guidewire was not stiff and the stainless steel was sticking out.It is most probable that the manner in which the device was handled and manipulated during the procedure and factors as tortuosity and/or patient anatomy could have induced the reported failures in the device.Since the complaint is associated with a product that meets the design & manufacture specification but, due to anatomical/procedural factors encountered during the procedure, performance was limited.Based on all gathered, the most probable root cause 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 an amplatz super stiff¿ guidewire was used during a ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the guidewire was not used as it was found not stiff and the stainless steel was sticking out.Reportedly, the guidewire remained intact as one and did not separate.The procedure was completed with a new amplatz super stiff¿ 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 fine.Investigation results revealed on october 12, 2017 that the core wire was broken.

• Brand Name: AMPLATZ SUPER STIFF¿
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6986781
• Report Number: 3005099803-2017-03216
• Device Sequence Number: 16371949
• Product Code: EZB
• UDI-Device Identifier: 08714729191193
• UDI-Public: 08714729191193
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

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: 12/15/2018
• Device Model Number: M0066401091
• Device Catalogue Number: 640-109
• Device Lot Number: 18741214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR