Model Number H7493895915300 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(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).
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Event Description
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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.
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Manufacturer Narrative
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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).
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Event Description
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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.
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Search Alerts/Recalls
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