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

Model Number	39575
Medical Device Problem Codes	Unraveled Material (1664); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when removing the guidewire, it became stuck on the stent causing it to unravel and separate leaving a portion of the tip unretrievable inside the patient.The target lesion was located in a non-tortuous and non-calcified bile duct.A st/035/145 (bx/5) amplatz super stiff guidewire was advanced for treatment of biliary stricture angioplasty and stenting, and also removal of previously placed 6fg pigtail drain.During the final part of stenting a biliary obstruction when removing the wire, it got caught on the far end of the stent and unraveled (detached tip was seen on imaging in the duodenum).No attempt was made to retrieve fragment because it was in the duodenum and if free may be expected to pass without complication.If the fragment was still attached to the stent, any attempts to remove may dislodge stent (in non-tortuous location).It was noted that only 3 cm length of wire was visible on x-ray exposure was difficult to see on fluoroscopy.The procedure had already been completed before this occurred, thus procedure was completed successfully.There were no additional interventions as a result, and the patient has fully recovered.

• 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: 16275569
• Report Number: 2124215-2023-03178
• Device Sequence Number: 4779077
• Product Code: DQX
• UDI-Device Identifier: 08714729115946
• UDI-Public: 08714729115946
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2023

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: 07/13/2025
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0029766725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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: Other
• Patient Sex: Unknown