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

Model Number	7522
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: approximately (b)(6) years old.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery.A 5.00mm x 15mm apex balloon catheter was advanced for dilatation.However, it was noted that the shaft had snapped at the rx portion inside the right coronary artery.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Returned product consisted of an apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks to the hypotube and shaft.There was a complete separation at the mid shaft bond.There was contrast inflation lumen and balloon, and blood in the guidewire lumen and inflation lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The inner was buckled 4.9cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Age at time of event: approximately (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery.A 5.00mm x 15mm apex balloon catheter was advanced for dilatation.However, it was noted that the shaft had snapped at the rx portion inside the right coronary artery.No patient complications were reported and the patient was fine.

• 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: 8723913
• Report Number: 2134265-2019-06378
• Device Sequence Number: 16645254
• Product Code: LOX
• UDI-Device Identifier: 08714729475699
• UDI-Public: 08714729475699
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2021
• Device Model Number: 7522
• Device Catalogue Number: 7522
• Device Lot Number: 0022025092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1