BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Catalog Number UNK ULTRAVERSE 014 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Vascular Dissection (3160); Embolism/Embolus (4438)
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Event Date 08/23/2021 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
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Event Description
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It was reported through an anonymous post-market survey of percutaneous transluminal angioplasty (pta) catheters that out of 50 total treatments, 5 were unsuccessful in tibial, 5 were unsuccessful in peroneal and there were 8 occurrences of flow-limiting dissection and 4 occurrences of distal embolization which required intervention.The current status of the patient(s) was not provided.
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Event Description
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It was reported through an anonymous post-market survey of percutaneous transluminal angioplasty (pta) catheters that out of fifty total treatments, five were unsuccessful in tibial, five were unsuccessful in peroneal and there were eight occurrences of flow-limiting dissection and four occurrences of distal embolization which required intervention.The current status of the patient(s) was not provided.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.The investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
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