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

Model Number	1865
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was difficult to remove.The target lesion was located in the calcified right coronary artery (rca).A 1.2mm x 12mm threader balloon catheter was advanced to treat the lesion.Physician was able to cross the lesion that required the use of a 1.5 burr rotablator.The threader was placed on the rotafloppy wire and the wire was exchanged out for a non-bsc wire.The threader was then used again in the case.It was difficult to remove the threader and it was thought the difficulty was due to needing the otw threader needing to be flushed better.The threader was then used again later in the case to exchange out for a new non-bsc wire and was flushed well with heparinized saline before placing on the wire.It went into the body with ease and the old non-bsc wire was removed.A new non-bsc wire was placed through the wire port of the otw threader and upon trying to remove the threader the physician was unable to remove the threader.A new non-bsc wire was placed next to the non-bsc wire/threader combo in the rca to re-wire the lesion in rca and the non-bsc wire/threader combo was removed.The single, new non-bsc wire was left in place.The patient was unharmed and case was successfully completed and lesions were stented.

• 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: 8556647
• Report Number: 2134265-2019-04443
• Device Sequence Number: 2232103
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: 03/11/2021
• Device Model Number: 1865
• Device Catalogue Number: 1865
• Device Lot Number: 0023472105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1