MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT; WIRE, GUIDE, CATHETER

Model Number	2783
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that guidewire tip detachment occurred requiring additional intervention.The target lesion was located in a moderately tortuous and calcified artery of the leg.A 300cm str pt guidewire was advanced for crossing the lesion.However, during the procedure, the tip of the wire broke off and was left in the artery of the patient.The physician used a snare and was able to remove the detached tip out from the patient's body.The procedure was completed with another device.No patient complications were reported and the patient was fully recovered.
Event or Problem Description
It was reported that guidewire tip detachment occurred requiring additional intervention.The target lesion was located in a moderately tortuous and calcified artery of the leg.A 300cm str pt guidewire was advanced for crossing the lesion.However, during the procedure, the tip of the wire broke off and was left in the artery of the patient.The physician used a snare and was able to remove the detached tip out from the patient's body.The procedure was completed with another device.No patient complications were reported and the patient was fully recovered.
Additional Manufacturer Narrative
E1: initial reporter city: (b)(6).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.Visual and microscope inspection showed distal tip detached and not returned.Guidewire kinked near to distal end.

• Brand Name: PT
• 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: 15447850
• Report Number: 2124215-2022-36434
• Device Sequence Number: 18020376
• Product Code: DQX
• UDI-Device Identifier: 08714729471226
• UDI-Public: 08714729471226
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K030617
• 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
• Report Date (Section B): 11/22/2022

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: 04/20/2024
• Device Model Number: 2783
• Device Catalogue Number: 2783
• Device Lot Number: 0029264859
• 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: 09/11/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Race: White