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

Model Number	M0066401061
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Visual examination of the returned guidewire revealed that the amplatz has the distal tip unraveled and the core wire kinked at the distal tip section.The core wire was detached from the ball weld.The complaint is consistent with the reported event that the coil wire was unraveled.Based on all gathered information, the most probable root cause is "handling damage." 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 in the ureter during a ureteroscopy performed on (b)(6) 2017.According to the complainant, during preparation, when the physician opened the packaging, it was found that the guidewire was broken through the coil overlay.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 (b)(6) 2017 that the guidewire 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: 6731828
• Report Number: 3005099803-2017-02265
• Device Sequence Number: 1371402
• Product Code: EZB
• UDI-Device Identifier: 08714729191162
• UDI-Public: (01)08714729191162(17)20200119(10)20183403
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/26/2017

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: Physician
• Device Expiration Date: 01/19/2020
• Device Model Number: M0066401061
• Device Catalogue Number: 640-106
• Device Lot Number: 20183403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1