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

Model Number 1865

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: patient is 18 years or older.(b)(6).

Event 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.

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 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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11396163
• MDR Text Key: 234229080
• Report Number: 2134265-2021-02547
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (y/n): N
• PMA/PMN Number: K134031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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