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

Model Number	39575
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the 1st day of the month of the bsc aware date since event date was not provided.
Event or Problem Description
It was reported that the wire frayed.A 035/180 amplatz super stiff guidewire was selected for use.However, it was noted that the end of the wire was frayed.The procedure was completed with a different device.No patient complications were reported and patient's status was fine.
Event or Problem Description
It was reported that the wire frayed.A 035/180 amplatz super stiff guidewire was selected for use.However, it was noted that the end of the wire was frayed.The procedure was completed with a different device.No patient complications were reported and patient's status was fine.
Additional Manufacturer Narrative
B3 date of event: used the 1st day of the month of the bsc aware date since event date was not provided.Device evaluated by mfr.: media inspection: in this case, the device was not returned, and despite the customer added a picture, it did not show the reported defect.The picture only showed the label that is stick to the front side of the pouch.The information contained in the label matched with the complaint information (batch/upn).The label was in good condition, it was completely legible and it did not show damages.No visual damages were observed in the picture provided.H3 other text : media.

• 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: 10325579
• Report Number: 2134265-2020-09759
• Device Sequence Number: 11565575
• Product Code: DQX
• UDI-Device Identifier: 08714729295730
• UDI-Public: 08714729295730
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K843013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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 Expiration Date: 02/19/2023
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0025238405
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1