MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066401081
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz wire was used in kidney during a procedure on (b)(6) 2022.During the procedure, the guidewire uncoiled and coilwire broke.The physician was able to grasp the detached portion and removed it from the patient.There were no patient complications reported as a result of this event.The patient's condition was reported to be doing fine.
Event or Problem Description
It was reported to boston scientific corporation that an amplatz wire was used in kidney during a procedure on march 23, 2022.During the procedure, the guidewire uncoiled and coilwire broke.The physician was able to grasp the detached portion and removed it from the patient.There were no patient complications reported as a result of this event.The patient's condition was reported to be doing fine.
Additional Manufacturer Narrative
Block h6 (device codes): device code a0501 captures the reportable event of coilwire broken.Block h10: the returned amplatz super stiff was analyzed.The guidewire tip was damaged, detached and stuck inside of flexima catheter.During product analysis, the guidewire unraveled.The coiled wire was found stretched and kinked along the distal end section and the corewire and coil were detached from the distal end.The reported event was confirmed.Based on the condition of the returned device, engineers determined that the problem observed is possibly due to the customer applying excessive force when trying to advance/release the device.This caused the guidewire to get damage at distal end section.In addition, the device was dimensional tested and the results were within specification and it was unloaded without issues from the stent.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14118956
• Report Number: 3005099803-2022-02093
• Device Sequence Number: 16713734
• Product Code: EZB
• UDI-Device Identifier: 08714729191186
• UDI-Public: 08714729191186
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2025
• Device Model Number: M0066401081
• Device Catalogue Number: 640-108
• Device Lot Number: 0028739604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male