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

Model Number	39615
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred.A 035/260/3mm (b/5) amplatz - pi guidewire was selected for use; however, during unpacking, it was found that the coating of the guidewire was damaged.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that coating issue occurred.A 035/260/3mm (b/5) amplatz - pi guidewire was selected for use; however, during unpacking, it was found that the coating of the guidewire was damaged.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluation by mfr: unit returned with its original pouch and overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned guidewire had the distal section stretched and unraveled.No more visual damages were found in the device.Outer diameter of distal tip, middle of the device, and proximal section are within specification.

• 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: 10608327
• Report Number: 2134265-2020-13356
• Device Sequence Number: 19533755
• Product Code: DQX
• UDI-Device Identifier: 08714729115861
• UDI-Public: 08714729115861
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K843012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 12/18/2022
• Device Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0024960030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR