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

Model Number	H7493895940250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product consisted of an apex balloon catheter.The balloon was loosely folded.The shaft, hypotube, and bonds were microscopically and visually examined.The hypotube was completely separated 73.2cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.There is tip damage.There were numerous hypotube and shaft kinks.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.A 2.50mm x 40mm apex balloon catheter was advanced to dilate the lesion.However, the device was pulled out from the patient's body and before inserting the device back into the patient, it was noted that the shaft broke.The procedure was completed with another of the same device.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: 6792514
• Report Number: 2134265-2017-08309
• Device Sequence Number: 16403643
• Product Code: LOX
• UDI-Device Identifier: 08714729475927
• UDI-Public: (01)08714729475927(17)20200524(10)20693393
• 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): 08/02/2017

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: 05/24/2020
• Device Model Number: H7493895940250
• Device Catalogue Number: 38959-4025
• Device Lot Number: 20693393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1