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	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in a vessel in the right arm.A 014/300/sst platinum plus guidewire was selected for use; however, the frayed tip broke off in the right brachial artery.The broken portion was not retrieved and the procedure was completed with a different device.No patient complications were reported and the patient status was normal.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in a vessel in the right arm.A 014/300/sst platinum plus guidewire was selected for use; however, the frayed tip broke off in the right brachial artery.The broken portion was not retrieved and the procedure was completed with a different device.No patient complications were reported and the patient status was normal.It was further reported via facility maude report mw5090039 that the broken tip was lodged extramural to brachial artery and so the physician decided to leave it there as it would cause more harm than good to remove the tip.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.It is possible to observe that the distal tip is bent, and the spring tip is damaged (unraveled).The outer diameter dimensions were found within specification.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in a vessel in the right arm.A 014/300/sst platinum plus guidewire was selected for use; however, the frayed tip broke off in the right brachial artery.The broken portion was not retrieved and the procedure was completed with a different device.No patient complications were reported and the patient status was normal.It was further reported via facility maude report mw5090039 that the broken tip was lodged extramural to brachial artery and so the physician decided to leave it there as it would cause more harm than good to remove the tip.

• 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: 9175295
• Report Number: 2134265-2019-12257
• Device Sequence Number: 2775312
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K945379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/19/2019

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: 04/10/2022
• Device Model Number: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0023631710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 10/16/2019; 11/07/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 10/31/2019; 11/19/2019
• 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: 40 YR