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Model Number H965SCH505100 |
Device Problems
Shaft (955); Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/17/2018 |
Event Type
Malfunction
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Manufacturer Narrative
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(b)(4).
Device evaluated by mfr: the device was returned for analysis.
A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.
A visual and microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.
The markerbands and tip section of the device were visually and microscopically examined and no issues were noted with the device that may have potentially contributed to the complaint incident.
The returned device was attached to an encore inflation unit.
(b)(6) pressure was applied and liquid was observed to be leaking from a shaft pinhole located approximately 7mm proximal to the proximal balloon bond.
The shaft of the returned device had stretching damage beginning approximately 4mm proximal of the proximal balloon bond and extending approximately 7mm proximately along the shaft.
The shaft was also kinked at several locations along its length.
This type of damage is consistent with excessive force being applied to the delivery system.
The shaft pinhole is located approximately in the middle of the shaft stretching.
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 investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.
(b)(4).
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Event Description
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Reportable based on device analysis completed on (b)(6) 2018.
It was reported that shaft leak occurred.
The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified shunt.
A 6.
0-40, 80mm wanda balloon catheter was advanced for pre-dilation.
Upon inflating the balloon, the pressure did not increase, it was noted that there was a leakage in the shaft part.
The procedure was completed with a different device.
No patient complications nor injuries were reported.
However, returned device analysis revealed shaft pinhole.
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Search Alerts/Recalls
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