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

Model Number	1865
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: patient is 18 years or older.(b)(6).
Event or Problem Description
It was reported that catheter entrapment occurred.The 90% stenosed, target lesion was located in the moderately tortuous and mildly calcified first diagonal branch of the left anterior descending artery.A 1.2mm x 12mm threader balloon catheter was advanced for dilatation.However, after the sixth inflation at 6 atmospheres for 5 seconds, the balloon was attempted to be removed but became stuck with the non-boston scientific guide wire.The threader balloon and the wire was then removed together as a unit and the procedure was completed with a non-boston scientific balloon catheter.No patient complications nor injuries reported.
Additional Manufacturer Narrative
A2: age at time of event: patient is 18 years or older.E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: returned product consisted of a threader balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The outer shaft was stretched down starting 140.2cm distal from the strain relief and extended the rest of the device.The device was functionally tested with a 0.014 inch guidewire.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported, that catheter entrapment occurred.The 90% stenosed, target lesion was located in the moderately tortuous.And mildly calcified first diagonal branch of the left anterior descending artery.A 1.2mm x 12mm threader balloon catheter was advanced for dilatation.However, after the sixth inflation at 6 atmospheres for 5 seconds, the balloon was attempted to be removed, but became stuck with the non-boston scientific guide wire.The threader balloon and the wire was then removed together as a unit.And the procedure was completed with a non-boston scientific balloon catheter.No patient complications nor injuries 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: 11396163
• Report Number: 2134265-2021-02547
• Device Sequence Number: 16969650
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 11/12/2021
• Device Model Number: 1865
• Device Catalogue Number: 1865
• Device Lot Number: 0024760284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 6F HYPERION JL3.5; GUIDE CATHETER: 6F HYPERION JL3.5; GUIDEWIRE: RUNTHROUGH; GUIDEWIRE: RUNTHROUGH; INTRODUCER SHEATH: 6F RADI FOCUS; INTRODUCER SHEATH: 6F RADI FOCUS