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

Model Number	40375
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in a vessel of the lower leg.A 014/300/sst platinum plus - pi guidewire was advanced.A 3.0mm x 60mm x 150cm, otw coyote balloon catheter was advanced for dilation.At some point during the procedure, the tip of the 014/300/sst platinum plus - pi guidewire unraveled.While attempting to remove the 3.0mm x 60mm x 150cm, otw coyote balloon catheter at the end of the procedure, the coyote balloon catheter and platinum plus pi guidewire could not be separated and were removed together from the patient.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in a vessel of the lower leg.A 014/300/sst platinum plus - pi guidewire was advanced.A 3.0mm x 60mm x 150cm, otw coyote balloon catheter was advanced for dilation.At some point during the procedure, the tip of the 014/300/sst platinum plus - pi guidewire unraveled.While attempting to remove the 3.0mm x 60mm x 150cm, otw coyote balloon catheter at the end of the procedure, the coyote balloon catheter and platinum plus pi guidewire could not be separated and were removed together from the patient.There were no patient complications nor injuries reported.It was further reported that the target lesion was 100% stenosed, severely calcified, and non-tortuous.
Additional Manufacturer Narrative
The device was returned for analysis loaded with a coyote balloon.The wire was inspected and the spring tip was noted to be damaged (detached, kinked and unraveled).The outer diameter dimensions were found within specification.
Event or Problem Description
It was reported that removal difficulties were encountered.The target lesion was located in a vessel of the lower leg.A 014/300/sst platinum plus - pi guidewire was advanced.A 3.0mm x 60mm x 150cm, otw coyote balloon catheter was advanced for dilation.At some point during the procedure, the tip of the 014/300/sst platinum plus - pi guidewire unraveled.While attempting to remove the 3.0mm x 60mm x 150cm, otw coyote balloon catheter at the end of the procedure, the coyote balloon catheter and platinum plus pi guidewire could not be separated and were removed together from the patient.There were no patient complications nor injuries reported.It was further reported that the target lesion was 100% stenosed, severely calcified, and non-tortuous.

• Brand Name: PLATINUM PLUS
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12771733
• Report Number: 2134265-2021-13890
• Device Sequence Number: 16930223
• Product Code: DQX
• UDI-Device Identifier: 08714729486886
• UDI-Public: 08714729486886
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: 40375
• Device Catalogue Number: 40375
• Device Lot Number: 0022877647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 12/01/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 11/18/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2018
• 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
• Patient Sex: Unknown