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

Model Number	1860
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10218895
• Report Number: 2134265-2020-08772
• Device Sequence Number: 19641646
• Product Code: LOX
• UDI-Device Identifier: 08714729848127
• UDI-Public: 08714729848127
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 09/08/2020
• 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: TERUMO RUNTHROUGH NS HYPERCOAT CORONARY GUIDEWIRE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR