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

Model Number	H7493895915200
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: returned product consisted of an apex balloon catheter.The balloon was loosely folded.The shaft, hypotube, and bonds were microscopically and visually examined.The shaft was completely separated 119.4cm from the hub.The fractured/separated ends of the shaft were stretched and jagged which indicates the shaft separation was due to tensile forces.There is tip damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There were numerous hypotube and shaft 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
Reportable based on device analysis completed on (b)(6) 2017.It was reported that shaft kink occurred.The target lesion was located in the right coronary artery.A 2.00mm x 15mm apex¿ balloon catheter was advanced but it was noted that the device delivery shaft was kinked.The procedure was completed with another 2.00mm x 15mm apex¿ balloon catheter.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed a broken shaft.

• 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: 7140914
• Report Number: 2134265-2017-12594
• Device Sequence Number: 1069085
• Product Code: LOX
• UDI-Device Identifier: 08714729475590
• UDI-Public: 08714729475590
• 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): 12/07/2017

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: 04/30/2020
• Device Model Number: H7493895915200
• Device Catalogue Number: 38959-1520
• Device Lot Number: 20496010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1