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

Model Number H7493895915300

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/18/2017

Event Type  malfunction  

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 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.

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 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¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6559404
• MDR Text Key: 74901468
• Report Number: 2134265-2017-04488
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729475637
• UDI-Public: (01)08714729475637(17)20200229(10)20293293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1