Model Number CQF7598 |
Device Problem
Deflation Problem (1149)
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Patient Problems
No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)
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Event Date 11/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending.The investigation of the reported event is currently underway.(expiry date: 06/2021).
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Event Description
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It was reported that during an angioplasty procedure in the cephalic vein, the pta balloon allegedly had difficulty deflating.A needle stick was used to deflate the balloon through the skin.The procedure was completed upon removal of the device.There was no reported patient injury.
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Event Description
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It was reported that during an angioplasty procedure in the cephalic vein, the pta balloon allegedly had difficulty deflating.A needle stick was used to deflate the balloon through the skin.The procedure was completed upon removal of the device.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the device was returned for evaluation.The device was prepped per the instructions for use, and inflated with a 10ml syringe.The device was then deflated within the specified time constraints, without any issues.Therefore, the investigation is unconfirmed for the reported deflation issue.The definitive root cause for the reported deflation issue could not be determined based upon available information.It is unknown whether procedural issues contributed to the event.Per the reported event details, the user alleged that a needle was inserted through the skin to deflate the balloon.It should be noted that the returned balloon did not exhibit any needle punctures.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
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Event Description
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It was reported that during an angioplasty procedure in the cephalic vein, the pta balloon allegedly had difficulty deflating.A needle stick was used to deflate the balloon through the skin.The procedure was completed upon removal of the device.There was no reported patient injury.
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Manufacturer Narrative
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The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.This supplemental emdr will be submitted to report the change in lot number, based on information received on 1/31/2019.
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Search Alerts/Recalls
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