MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; ENDOSCOPE AND/OR ACCESSORIES

Model Number	M00550090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an amplatz super stiff guidewire was used in the esophagus during a procedure performed on (b)(6) 2018.According to the complainant, during the procedure, a non bsc device was introduced over the amplatz super stiff guidewire.It was then noticed that the core wire was broken.The procedure was completed with a new amplatz super stiff guidewire.There were no complications reported as a result of this event.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.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7905158
• Report Number: 3005099803-2018-60593
• Device Sequence Number: 1807156
• Product Code: OCY
• UDI-Device Identifier: 08714729301929
• UDI-Public: 08714729301929
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K944959
• 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): 09/25/2018

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: 05/23/2021
• Device Model Number: M00550090
• Device Catalogue Number: 47315
• Device Lot Number: 0022166368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1