MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493895915250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: the device was not returned for analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-02227.It was reported that balloon rupture occurred.The 40%- 99% stenosed, tubular diffuse, in-stent restenotic target lesion was located in the proximal to mid left anterior descending artery.A 2.50mm x 15mm apex¿ balloon catheter was advanced for dilatation, however, the balloon ruptured on second inflation at 16 atmospheres.A 3.00mm x 15mm apex¿ balloon catheter was also used and during first inflation at 12 atmospheres the balloon ruptured.The devices were completely removed from the patient and the procedure was completed with 3.0x15 nc quantum apex balloon catheter.No patient complications were reported and the patient's status was stable.

• Brand Name: APEX¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7374319
• Report Number: 2134265-2018-02233
• Device Sequence Number: 13880746
• Product Code: LOX
• UDI-Device Identifier: 08714729475613
• UDI-Public: 08714729475613
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 03/02/2018

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: 11/26/2020
• Device Model Number: H7493895915250
• Device Catalogue Number: 38959-1525
• Device Lot Number: 21438215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR