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

Model Number	39575
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire peeling occurred.The patient presented with lower limb peripheral artery disease (pad).The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified illiac artery.A 035/260/1 (bx/1) amplatz super stiff guide catheter was used for treatment.However, during insertion, a black polymer part of the guidewire spring coil tip peeled off.The procedure was completed with a different device and the device was removed intact.There were no patient complications reported and the patient condition is good.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned with its original pouch, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The guidewire was returned, and it was observed that the coil wire was unraveled due the core wire was found detached separated from distal tip to the transition point.Additionally, the guidewire was kinked in the distal section.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No more damages were observed.
Event or Problem Description
It was reported that guidewire peeling off occurred.The patient presented with lower limb peripheral artery disease (pad).The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified illiac artery.A 035/260/1 (bx/1) amplatz super stiff guide catheter was used for treatment.However, during insertion, a black polymer part of the guidewire spring coil tip peeled off.The procedure was completed with a different device and the device was removed intact.There were no patient complications reported and the patient condition is good.

• 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: 17800083
• Report Number: 2124215-2023-47789
• Device Sequence Number: 17815489
• Product Code: DQX
• UDI-Device Identifier: 08714729295655
• UDI-Public: 08714729295655
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0031158957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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
• Patient Sex: Unknown