Model Number H7493892815150 |
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 08/10/2016 |
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 unpacking of a 1.50mm x 15mm maverick 2 (tm) balloon catheter, it was noted that the shaft was broken.The procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter with no other devices.The balloon was tightly folded and there was blood in the lumen.The hypotube, inner shaft and outer shaft were microscopically and tactile inspected.Inspection revealed a total separation in the hypotube 60cm from the strain relief, with numerous kinks in the hypotube.The fracture faces were oval as if kinked prior to separation.There was no evidence of any material or manufacturing deficiencies.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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).
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Event Description
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It was reported that shaft break occurred.During unpacking of a 1.50mm x 15mm maverick²¿ balloon catheter, it was noted that the shaft was broken.The procedure was completed with another of the same device.No patient complications were reported.
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Search Alerts/Recalls
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