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

Model Number 39575

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that tip detachment occurred.A 035/260/1 (bx/1) amplatz super stiff guidewire was selected for use.The device was unpacked and attempted to be inserted into the sheath, the tip was noted to be chipped.A second guidewire was used to complete the procedure.No complications were reported.

Manufacturer Narrative

Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).

Manufacturer Narrative

E1: initial reporter address 1:(b)(6).E1: initial reporter city: (b)(6).Device evaluated by mfr.: the amplatz super stiff guidewire was returned for analysis.A visual examination observed that the guidewire was bent and stretched at the distal tip section.Tip detachment was not confirmed.

Event Description

It was reported that tip detachment occurred.A 035/260/1 (bx/1) amplatz super stiff guidewire was selected for use.The device was unpacked and attempted to be inserted into the sheath, the tip was noted to be chipped.A second guidewire was used to complete the procedure.No complications were reported.

• Brand Name: AMPLATZ SUPER STIFF
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18899128
• MDR Text Key: 337660044
• Report Number: 2124215-2024-14255
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729295655
• UDI-Public: 08714729295655
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K843012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0032712373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2023
• 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