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

Model Number	7528
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The chronic totally occluded target lesion was located in the right coronary artery.A 3.50mm x 40mm apex balloon catheter was advanced for dilation.However, it was noted that the device got stuck in the heavy calcification and when trying to remove with force, the shaft broke into two pieces.The device was completely removed together with the wire and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The distal section of the device is missing.The missing parts are the tip, marker band, distal section of the balloon, and distal section of the guidewire lumen.From the hub to the separated balloon is approximately 148.7cm and from the hub to the separated guidewire lumen is approximately 147.5cm.Microscopic examination revealed that the guidewire lumen is stretched 145.6cm from the hub and goes to the separation which makes it approximately 1.9cm long.There is blood present in the hub, inflation lumen, and balloon.The balloon is loosely folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The chronic totally occluded target lesion was located in the right coronary artery.A 3.50mm x 40mm apex balloon catheter was advanced for dilation.However, it was noted that the device got stuck in the heavy calcification and when trying to remove with force, the shaft broke into two pieces.The device was completely removed together with the wire and the procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8374910
• Report Number: 2134265-2019-01798
• Device Sequence Number: 14002949
• Product Code: LOX
• UDI-Device Identifier: 08714729475941
• UDI-Public: 08714729475941
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• 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): 04/08/2019

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: 10/15/2021
• Device Model Number: 7528
• Device Catalogue Number: 7528
• Device Lot Number: 22801136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1