Model Number IPN000074 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported by (b)(6) lab at (b)(6) hospital.It was reported that balloon burst while in use.Three follow up attempts were made to obtain additional information regarding the patient condition and if the device is available for return but they were unsuccessful.If we received additional information, the complaint file will be updated.
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Event Description
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It was reported by (b)(6) supply coor caradic cath lab at (b)(6) hospital.It was reported that balloon burst while in use.Three follow up attempts were made to obtain additional information regarding the patient condition and if the device is available for return but they were unsuccessful.If we received additional information, the complaint file will be updated.
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Manufacturer Narrative
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Qn#(b)(4).The product was not returned for investigation.The reported complaint that the "balloon burst while in use" is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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