Model Number B1030-040 |
Device Problems
Break (1069); Inflation Problem (1310); Material Separation (1562)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was performed to treat an unspecified lesion.The 3.0x40mm armada 35 balloon could not be fully inflated as the hub was cracked at the inflation port threading.The balloon was used at nominal pressure as full angioplasty was not needed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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A visual and functional inspection was performed on the returned device.The reported difficulties were unable to be confirmed as no cracks, or damages were noted on the hub and the device was able to inflate and hold pressure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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Event Description
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It was reported that the procedure was performed to treat an unspecified lesion.The 3.0x40mm armada 35 balloon could not be fully inflated as the hub was cracked at the inflation port threading.The balloon was used at nominal pressure as full angioplasty was not needed.There were no adverse patient effects and no clinically significant delay in the procedure.Additional information received subsequent to filing the initial report: the inflation hub had a tiny piece of the plastic rim missing, resulting in an inadequate seal.No additional information was provided.
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Search Alerts/Recalls
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