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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual examination of the returned guidewire revealed that the distal section was unraveled.The core wire was separated from the welding ball on its distal end.Also, it shows a kink approximately at 42 cm from its proximal end.The complaint is consistent with the returned device that the distal section was unraveled.The core wire was separated from the welding ball located at the most distal part of the device and kink on its body.It is most probable that anatomical/procedural factors could have generated the failure encountered.Based on all gathered information, 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 a procedure.The procedure date is unknown.According to the complainant, the amplatz guidewire was shredded.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Investigation results revealed on (b)(6) 2018 that the core wire separated from the welding ball on its distal end.

• 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: 7726882
• Report Number: 3005099803-2018-02335
• Device Sequence Number: 19081719
• Product Code: EZB
• UDI-Device Identifier: 08714729191162
• UDI-Public: 08714729191162
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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: 12/17/2020
• Device Model Number: M0066401061
• Device Catalogue Number: 640-106
• Device Lot Number: 0021527541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1