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

Model Number	1860
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 1.2mm x 12mm threader balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 1.2mm x 12mm threader balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported.It was further reported the lesion was severely stenosed and was located in the severely tortuous and moderately calcified artery.It was noted that the balloon was ruptured at rated burst pressure.
Additional Manufacturer Narrative
Updated b5: describe event or problem - additional information.Device evaluated by mfr.: the device was returned for analysis.The shafts, tip, and balloon were microscopically and visually examined.There was blood in the inflation lumen and balloon.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device to rated burst pressure.When the balloon was inflated, fluid leaked from the balloon.Microscopic examination revealed that there was a pinhole in the balloon material at the distal edge of the markerband.The markerband was inspected and there was no damage or irregularities.Product analysis confirmed the reported event, as there was a hole in the balloon.

• 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: 9601351
• Report Number: 2134265-2019-16814
• Device Sequence Number: 2500856
• Product Code: LOX
• UDI-Device Identifier: 08714729848127
• UDI-Public: 08714729848127
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K134031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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: 11/06/2020
• Device Model Number: 1860
• Device Catalogue Number: 1860
• Device Lot Number: 0022902008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1