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

Model Number 39575

Device Problems Difficult to Insert (1316); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Unit returned with its original pouch.Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was slightly kinked at the distal tip.On the other hand, the device was inspected under high magnification at a distance of 8 inches from the distal tip and it was found that the device was a little scratched.The overall length, outer diameter (od) of distal tip, od of middle of the device and od of proximal section were within specifications.

Event Description

Reportable based on device analysis completed on 12jun2019.It was reported that guidewire deformation occurred and guide wire insertion difficulties were encountered.During preparation of a 035/260/1 (bx/1) amplatz super stiff guide wire, it was noted that the taper was frayed 8 inches from the distal end and it was unable to load in the sheath.The procedure was completed with a new wire.No patient complications were reported.However, returned device analysis revealed guide wire coating peeled/sheared.

• Brand Name: AMPLATZ SUPER STIFF
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; ,; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8746732
• MDR Text Key: 149638809
• Report Number: 2134265-2019-07164
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729295655
• UDI-Public: 08714729295655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K843012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0021201837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 06/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1