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

Model Number	H7493895915300
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.During preparation of a 3.00mm x 15mm apex¿ balloon catheter, when the stylet was removed from the tip of the balloon, it was noted that the shaft separated at the proximal monorail port.The device was not used inside the patient and the procedure was completed with another 3.00mm x 15mm apex 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 the proximal portion of the apex balloon catheter.The distal shafts after the exit notch, the balloon, markerbands, and tip were not returned for analysis.The hypotube and portion of the shaft that was returned for analysis was microscopically examined.The distal shaft was stretched 2.5mm ¿ 7.5mm distal of the exit notch and separated 7.5mm distal of the exit notch.The separated end of the shaft appeared to be jagged and damaged, which indicates that the separation was due to tensile overload.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that shaft break occurred.During preparation of a 3.00mm x 15mm apex¿ balloon catheter, when the stylet was removed from the tip of the balloon, it was noted that the shaft separated at the proximal monorail port.The device was not used inside the patient and the procedure was completed with another 3.00mm x 15mm apex 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: 6559404
• Report Number: 2134265-2017-04488
• Device Sequence Number: 1134647
• Product Code: LOX
• UDI-Device Identifier: 08714729475637
• UDI-Public: (01)08714729475637(17)20200229(10)20293293
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 04/20/2017

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: 02/29/2020
• Device Model Number: H7493895915300
• Device Catalogue Number: 38959-1530
• Device Lot Number: 20293293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1