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

Model Number	H7493895912200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.A 2.00mm x 12mm apex¿ balloon catheter was advanced for dilatation.However, upon inflation, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another balloon catheter.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The balloon was loosely folded with blood in the inflation lumen and balloon.The tip is damaged.Microscopic examination revealed that the balloon has a pinhole at the proximal balloon cone.There are numerous hypotube kinks.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
It was reported that balloon rupture occurred.A 2.00mm x 12mm apex¿ balloon catheter was advanced for dilatation.However, upon inflation, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another balloon catheter.No patient complications were reported and the patient's status was fine.

• 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: 7053205
• Report Number: 2134265-2017-11543
• Device Sequence Number: 19058257
• Product Code: LOX
• UDI-Device Identifier: 08714729475477
• UDI-Public: 08714729475477
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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: 01/31/2020
• Device Model Number: H7493895912200
• Device Catalogue Number: 38959-1220
• Device Lot Number: 0020205719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1