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

Model Number	39615
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of aware date as there was no date provided.
Event or Problem Description
It was reported that the package of the device was opened.An amplatz super stiff guidewire was received with the package opened.No further information was available.
Additional Manufacturer Narrative
Date of event: used the first day of the month of aware date as there was no date provided.Device evaluated by mfr.: the device was retruned for analysis.The device was returned inside of the original pouch, however the original pouch was partially opened.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 that it was opened after it left the manufacturing floor.The carboard box had some sections torn.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
It was reported that the package of the device was opened.An amplatz super stiff guidewire was received with the package opened.No further information was available.

• 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: 9252056
• Report Number: 2134265-2019-12720
• Device Sequence Number: 14031135
• 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,Followup
• 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: Health Professional
• 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
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement 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