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

Model Number 1860

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/02/2020

Event Type  Injury  

Event Description

It was reported that the device became stuck in the anatomy.A 1.75mm rotapro, 330cm rotawire, and 1.2mm x 12mm threader were used in a percutaneous coronary intervention in the mid right coronary artery (rca).During the procedure, the devices became stuck in the mid rca and were unable to be removed from the body.The devices were left inside the body.

Event Description

It was reported that the device became stuck in the anatomy.A 1.75mm rotapro, 330cm rotawire, and 1.2mm x 12mm threader were used in a percutaneous coronary intervention in the mid right coronary artery (rca).During the procedure, the devices became stuck in the mid rca and were unable to be removed from the body.The devices were left inside the body.It was further reported that a non-bsc guidewire also became entrapped during this procedure.

• 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: 10218895
• MDR Text Key: 197157559
• Report Number: 2134265-2020-08772
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729848127
• UDI-Public: 08714729848127
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2022
• Device Model Number: 1860
• Device Catalogue Number: 1860
• Device Lot Number: 0025196480
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TERUMO RUNTHROUGH NS HYPERCOAT CORONARY GUIDEWIRE.
• Patient Outcome(s): Other
• Patient Age: 78 YR