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

Model Number	40375
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the wire came off and was lodged in the anterior tibial artery.A 0.014 inch, 300cm platinum plus guidewire was selected for use in an angioplasty procedure of the anterior tibial artery.During the procedure, the tip of the guidewire detached and became lodged in the anterior tibial artery.The procedure was stopped.The patient came to no harm and was stable.At this time, the physician does not feel that the patient would benefit from an operation to remove the tip.The tip is in the occluded portion of the artery and is not likely to migrate or cause any issues in mri.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the product was returned with the original pouch and with a non-boston scientific catheter.Visual examination of the device showed the distal section of the wire was kinked and the spring tip was damaged.Under the microscope it was further confirmed that the spring tip was stretched and unraveled, and broken at the very tip.The device was measured and was within specification.
Event or Problem Description
It was reported that the tip of the wire came off and was lodged in the anterior tibial artery.A 0.014 inch, 300cm platinum plus guidewire was selected for use in an angioplasty procedure of the anterior tibial artery.During the procedure, the tip of the guidewire detached and became lodged in the anterior tibial artery.The procedure was stopped.The patient came to no harm and was stable.At this time, the physician does not feel that the patient would benefit from an operation to remove the tip.The tip is in the occluded portion of the artery and is not likely to migrate or cause any issues in mri.It was further reported that the lesion was totally occluded with a mixture of plaque and calcium.The lesion was in a straight vessel.

• Brand Name: PLATINUM PLUS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11496542
• Report Number: 2134265-2021-03373
• Device Sequence Number: 3997744
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K945379
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 03/12/2023
• Device Model Number: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0025349179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/19/2021
• 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: Other
• Patient Age: 62 YR