BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Model Number CQF75124 |
Device Problems
Difficult to Flush (1251); Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records will 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.(expiry date: 12/2023).
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Event Description
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It was reported that prior to a procedure through the left upper arm fistula to treat the subclavian vein, the catheter allegedly would not fill with contrast.The procedure was completed using another device.There was no patient contact.
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Event Description
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It was reported that prior to a pta balloon dilatation catheter placement procedure through the left upper arm fistula to treat the subclavian vein, the catheter allegedly would not fill with contrast.The procedure was completed using another device.There was no patient contact.
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Manufacturer Narrative
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H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: as the lot number for the device was provided, a review of the device history records will 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.H10: b5, d4 (expiry date: 12/2023).H11: section a through f: the information provide by bd represents all 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.
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