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

Model Number	M0066401081
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned guidewire revealed that the amplatz was broken and bent.The distal tip was also unraveled.The complaint is consistent with the reported event that the coil wire was unraveled.It is most probable that anatomical/procedural factors like interaction with other devices or while the device was advancing through the lesion target could have generated the failures reported.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 in the ureter during a retrograde intrarenal surgery procedure performed on (b)(6) 2016.According to the complainant, during the procedure, after placement of the stent into the ureter using the pusher through the cystoscope, resistance was met when the amplatz guidewire was pulled out from the pusher.The pusher and the amplatz guidewire were removed together and it was found that the coil wire of the guidewire was unraveled.The procedure was completed with this device.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 stable.Investigation results revealed on may 29, 2017 that the core wire is 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: 6660162
• Report Number: 3005099803-2017-01926
• Device Sequence Number: 18887160
• Product Code: EZB
• UDI-Device Identifier: 08714729191186
• UDI-Public: (01)08714729191186(17)20171201(10)0017504637
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2017

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: 12/01/2017
• Device Model Number: M0066401081
• Device Catalogue Number: 640-108
• Device Lot Number: 0017504637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2017
• Initial Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1