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

Model Number	H7493895912200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product consisted of an apex balloon catheter.The balloon was loosely folded with contrast in the inflation lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.There are numerous hypotube and shaft kinks.The shaft is damaged at the exit notch which is consistent with the use of a guidewire.Microscopic examination revealed that there is a 2.5mm circumferential tear 3mm from the proximal markerband.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 27jul2018.It was reported that balloon leak occurred.During preparation of a 2.00mm x 12mm apex¿ balloon catheter, it was noted that the balloon was leaking gas and could not fully expand.The device was replaced and the procedure was completed with another 2.00mm x 12mm apex¿ balloon catheter.No patient complications were reported and the patient's status was stable.However, returned device analysis balloon torn circumferentially.

• 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: 7789823
• Report Number: 2134265-2018-07316
• Device Sequence Number: 1287194
• Product Code: LOX
• UDI-Device Identifier: 08714729475477
• UDI-Public: 08714729475477
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2018

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: 01/31/2020
• Device Model Number: H7493895912200
• Device Catalogue Number: 38959-1220
• Device Lot Number: 0020156792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1