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

Model Number	1860
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 1.2mm x 12mm threader balloon catheter was advanced but resistance was felt and the shaft got severely kinked and had been separated when trying to advanced.The physician used another 1.2mm x 12mm threader balloon catheter and the same issues were encountered.The procedure was successfully completed with another of the same device and no adverse events reported and the patient was alright.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a threader balloon catheter.The balloon was loosely folded with blood on the outside of the device and contrast inside the balloon and inner lumen.The device was in a warm waterbath for 7 days.The tip, balloon, markerbands, and inner/outer shafts were microscopically and tactile inspection.Inspection revealed a kink in the shaft located 22.8 cm from the tipoff the device, and slight tip damage.Functional testing was done by attaching an inflation device filled with water to the hub.When pressure was applied, a pinhole was found in the balloon material, at the distal edge of the distal markerband.Inspection found the rest of the device free of damage.The kink in the device was severe and would make the usage of the device difficult, and it is likely that the customer perceived the device broken.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 1.2mm x 12mm threader balloon catheter was advanced but resistance was felt and the shaft got severely kinked and had been separated when trying to advanced.The physician used another 1.2mm x 12mm threader balloon catheter and the same issues were encountered.The procedure was successfully completed with another of the same device and no adverse events reported and the patient was alright.

• 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: 8075418
• Report Number: 2134265-2018-62964
• Device Sequence Number: 16709687
• Product Code: LOX
• UDI-Device Identifier: 08714729848127
• UDI-Public: 08714729848127
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 01/09/2019

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: 09/10/2020
• Device Model Number: 1860
• Device Catalogue Number: 1860
• Device Lot Number: 0022637062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1