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

Model Number	39615
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire was entangled through the sheath requiring additional device, and a foreign matter was found on the guidewire.A 035/180/3mm (b/1) amplatz super stiff guidewire used during pacemaker replacement and was inserted into a non-boston scientific (bsc) introducer sheath.However, during introduction, the guidewire was entangled within the superior vena cava (svc) and a knot was formed.A non-bsc introducer sheath was used to remove the guidewire.After removal, it was found that a white foreign material was entangled at the tip of the guidewire.It was unknown if the foreign matter originated from biological material or from the device itself.Another amplatz super stiff guidewire was used to complete the procedure.There were no patient complications as result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.It was observed that it was bent and tangle at distal tip.Also, what is seen as "foreign material" is not something that the guidewire could cause.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the guidewire was entangled through the sheath requiring additional device, and a foreign matter was found on the guidewire.A 035/180/3mm (b/1) amplatz super stiff guidewire used during pacemaker replacement and was inserted into a non-boston scientific (bsc) introducer sheath.However, during introduction, the guidewire was entangled within the superior vena cava (svc) and a knot was formed.A non-bsc introducer sheath was used to remove the guidewire.After removal, it was found that a white foreign material was entangled at the tip of the guidewire.It was unknown if the foreign matter originated from biological material or from the device itself.Another amplatz super stiff guidewire was used to complete the procedure.There were no patient complications as result of this event.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: 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: 23084250
• Report Number: 2124215-2025-65129
• Device Sequence Number: 20030194
• Product Code: DQX
• UDI-Device Identifier: 08714729295648
• UDI-Public: (01)08714729295648(17)280429(10)36415235
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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 Model Number: 39615
• Device Catalogue Number: 39615
• Device Lot Number: 0036415235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown