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

Model Number	1860
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that shaft break and difficulty removal were encountered.The target lesion was located in the left anterior descending artery.After dilatation using a 1.2mm x 12mm threader catheter, the physician noticed that the device was hard to remove from the body and it broke in a half.The device was completely removed from the patient and the procedure was completed with a different device.No patient complications were reported.

• Brand Name: THREADER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7980966
• Report Number: 2134265-2018-62074
• Device Sequence Number: 13834431
• Product Code: LOX
• UDI-Device Identifier: 08714729848127
• UDI-Public: 08714729848127
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K134031
• 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
• Report Date (Section B): 10/18/2018

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: 08/06/2020
• Device Model Number: 1860
• Device Catalogue Number: 1860
• Device Lot Number: 0022477522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/18/2018
• Patient Sequence Number: 1