Catalog Number B1050-040 |
Device Problems
Entrapment of Device (1212); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that the procedure was to treat an unspecified peripheral artery.A 5.0 x 40 mm armada 35 balloon catheter was used and did not meet any resistance during advancement.However, the balloon ruptured during the first inflation below the rated burst pressure.Then, during removal, the balloon became caught in an unspecified implanted stent.Therefore, the patient was sent to surgery to remove the balloon.There was no adverse patient sequela reported.No additional information was provided.
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Manufacturer Narrative
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(b)(4).Date of event and angiography date changed from (b)(6) 2018 to (b)(6) 2018.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined that the reported difficulties appear to be related to circumstances of the procedure.There was no damage noted to the sds catheter during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.
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Event Description
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Subsequent to the initial report, additional information was received.The balloon was removed during surgery, and another unspecified balloon dilatation catheter was used to successfully complete the procedure.The patient is stable.No additional information was provided.
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Search Alerts/Recalls
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