Model Number M001PCB8020900 |
Device Problems
Detachment Of Device Component (1104); Entrapment of Device (1212); Torn Material (3024)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.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 the balloon ripped and became stuck.An 8.00mm/2.0cm/90cm peripheral cutting balloon® was selected for use.During the procedure, it was noted that the balloon ruptured and ripped.Subsequently, the balloon became stuck.No patient complications were reported.
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Manufacturer Narrative
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Ae or product problem corrected from product problem to reported issue both an adverse event and product problem.Outcomes attributed to ae, describe event or problem, name prefix, last name, patient codes, device codes updated.(b)(4).
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Event Description
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It was further reported that the physician attempted to pull the balloon catheter into the guide catheter; however, the balloon snapped off.Snaring was done to remove the balloon out from the patient's body.Patient's condition after the procedure was stable.
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Search Alerts/Recalls
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