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

Model Number	39575
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties were encountered and the procedure was prolonged.A 035/145 amplatz superstiff guidewire was selected for use.However, during the procedure, the guidewire became stuck in "mono j".The physician had to remove the whole system and the procedure which was supposed to last 10 minutes lasted 2 hours.The procedure was completed.No patient complications were reported, however, the patient was further hospitalized.

• Brand Name: AMPLATZ SUPER STIFF
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12644451
• Report Number: 2134265-2021-12838
• Device Sequence Number: 16500823
• Product Code: DQX
• UDI-Device Identifier: 08714729295716
• UDI-Public: 08714729295716
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K843015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/17/2021

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: 09/21/2023
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0026053796
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 10/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 39 YR
• Patient Weight: 70