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

Model Number	7528
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 4.00mm x 40mm apex ballloon catheter was selected for use.However, the balloon ruptured during preparation.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an apex mr balloon catheter.The device was microscopically and visually examined.There were numerous kinks to the device.There was contrast in the inflation lumen.At 67mm from the tip of the device, the guidewire lumen was buckled with a hole for a length of 1mm.The balloon was tightly folded, and contrast was present in the balloon folds.Product analysis confirmed the reported rupture, as a hole was present in the guidewire lumen buckle.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.00mm x 40mm apex ballloon catheter was selected for use.However, the balloon ruptured during preparation.The procedure was completed with a different device.There were no patient complications 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: 11946676
• Report Number: 2134265-2021-07286
• Device Sequence Number: 1060368
• Product Code: LOX
• UDI-Device Identifier: 08714729475958
• UDI-Public: 08714729475958
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 02/26/2022
• Device Model Number: 7528
• Device Catalogue Number: 7528
• Device Lot Number: 0023407975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1