MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number	39615
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the unit received into its partially opened pouch.The received pouch returned inside of a cardboard box with four more devices.The card board box had double tear tab closure strips, which means it was opened after it left the manufacturing floor.The cardboard box had some sections torn.The device of this complaint returned inside of a partially opened pouch.A hoop containing an amplatz guidewire was inside this pouch and no visual damages were observed in the hoop/guidewire.The returned pouch had the upper left side opened.The sealed marks found on the pouch indicates that it was correctly sealed.The labels, the front side and back side of the pouch were in good condition, no indentations, holes nor perforations were found.
Event or Problem Description
Reportable based on device analysis completed on 19-dec-2019.A 035/260/3mm amplatz super stiff guidewire was returned with no reported allegations.However, device analysis revealed the foil seal was partially opened.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9540895
• Report Number: 2134265-2019-16287
• Device Sequence Number: 2299971
• Product Code: DQX
• UDI-Device Identifier: 08714729741350
• UDI-Public: 08714729741350
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/02/2020

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: Other
• Device Expiration Date: 02/10/2022
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0023330440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1