MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION THREADER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1865
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was defective and the procedure was canceled.The patient presented for a complex percutaneous coronary intervention.A 1.2mm x 12mm threader balloon catheter was advanced for dilation but was unable to cross the lesion and the procedure was canceled.There were no patient complications.
Event or Problem Description
It was reported that crossing difficulty led to procedure cancellation occurred.A 1.2mm x 12mm threader balloon catheter was advanced for dilation.However, the device was not able to cross the lesion.The procedure was cancelled and there were no patient complications nor injuries reported.
Additional Manufacturer Narrative
The returned product consisted of a threader otw balloon catheter.The device was microscopically and visually examined.At 22.7cm-23.8cm and 27cm-29.5cm from the strain relief, the coil shaft was buckled.At a total length of 8.3cm proximal to the tip, the shaft was buckled, and the balloon was buckled or accordioned up to the tip of the device.The tip of the device was damaged.There was contrast and blood present in the shaft of the device as well as the balloon.

• Brand Name: THREADER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12576035
• Report Number: 2134265-2021-12219
• Device Sequence Number: 3488402
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K134031
• 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
• Report Date (Section B): 11/08/2021

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: 02/10/2023
• Device Model Number: 1865
• Device Catalogue Number: 1865
• Device Lot Number: 0026783826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2021
• 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