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

Model Number	39575
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a detachment occurred requiring surgery.The moderately stenosed target lesion was located in the mildly calcified and moderately tortuous subclavian artery.An amplatz super stiff guidewire was selected for use in a subclavian vein, recanalization procedure.While inserting the guidewire into the introducer sheath, the guidewire did not advance.The guidewire unsheathed and detached inside the patient.Surgery was required to remove the remaining piece of the guidewire.The patient hospitalization was prolonged and their status is good.
Event or Problem Description
It was reported that a detachment occurred requiring surgery.The moderately stenosed target lesion was located in the mildly calcified and moderately tortuous subclavian artery.An amplatz super stiff guidewire was selected for use in a subclavian vein recanalization procedure.While inserting the guidewire into the introducer sheath, the guidewire did not advance.The guidewire unsheathed and detached inside the patient.Surgery was required to remove the remaining piece of the guidewire.The patient hospitalization was prolonged and their status is good.
Additional Manufacturer Narrative
H6: impact codes: updated from additional surgery to surgical intervention.
Event or Problem Description
It was reported that a detachment occurred requiring surgery.The moderately stenosed target lesion was located in the mildly calcified and moderately tortuous subclavian artery.An amplatz super stiff guidewire was selected for use in a subclavian vein recanalization procedure.While inserting the guidewire into the introducer sheath, the guidewire did not advance.The guidewire unsheathed and detached inside the patient.Surgery was required to remove the remaining piece of the guidewire.The patient hospitalization was prolonged and their status is good.
Additional Manufacturer Narrative
H6: impact codes: updated from additional surgery to surgical intervention.Device evaluated by mfr: the product was returned to boston scientific for analysis.Microscopic and visual inspection revealed the coil wire was detached at the distal section, also the core wire was detached at distal section and for this reason the coil wire was unraveled.The outer diameter of the distal tip, middle section and proximal sections passed dimensional inspection.The length of the detached core wire fragment from the distal tip to the detached point is 2.7cm.The rest of the core wire length is 142.4 cm.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15225976
• Report Number: 2124215-2022-30128
• Device Sequence Number: 5633945
• Product Code: DQX
• UDI-Device Identifier: 08714729115946
• UDI-Public: 08714729295723
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K843017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2022

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: 05/23/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0029462719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 08/31/2022; 11/29/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/29/2022; 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown