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

Model Number	39575
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that device entrapment occurred.The 99% stenosed target lesion was located in the moderately tortuous bile duct.A mustang balloon catheter and a 035/145 amplatz super stiff guidewire were selected for use.However, when the balloon catheter passed through the wire, it was caught in the wire body and was unable to be inserted further.It was noted that the proximal part was bulging.Both devices were removed together and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
E1- initial reporter facility name: (b)(6) hospital.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 tip of the guidewire was kinked, and the coil wire was unraveled at distal tip section.The core wire at 5.2cm from distal tip, also it was detachment/separated a fragment of the core wire with length of 0.3cm.Under microscope it was observed that the core wire was detached.The middle section and proximal section outer diameter were within specification.However, the distal tip and the overall length could not be measured due the several damages condition of the device.Boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported that device entrapment occurred.The 99% stenosed target lesion was located in the moderately tortuous bile duct.A mustang balloon catheter and a 035/145 amplatz super stiff guidewire were selected for use.However, when the balloon catheter pass through the wire, it was caught in the wire body and was unable to inserted further.It was noted that the proximal part was bulging.Both devices were removed together and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• 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: 15321194
• Report Number: 2124215-2022-31325
• Device Sequence Number: 5888827
• Product Code: DQX
• UDI-Device Identifier: 08714729115809
• UDI-Public: 08714729115809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K843016
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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: 02/20/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0028911166
• 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: 08/10/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2022
• 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
• Patient Sex: Unknown