MERIT MEDICAL MANUFACTURING .IMPRESS®.BRAIDED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Catalog Number 56538CB1-H |
Device Problems
Break (1069); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2023 |
Event Type
Injury
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Event Description
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The account alleges that during a surgical abdominal aortic stent implant procedure [aaa] on a female patient, the proximal hydrophilic segment of the 5f catheter detached within the patient.The physician had acquired retrograde femoral artery access to deliver a coil-type embolic devices, during catheter manipulations over a guidewire under fluoroscopy, the catheter tip detached within the patient's common iliac artery.The physician used a vascular snare device to successfully externalize the fragmented foreign bodies, but the foreign body again was fragmented.A thrombectomy catheter was eventually used to remove all fragmented parts liberating the patient's vessel.No additional patient consequences to report.
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Manufacturer Narrative
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The suspect medical device will not be returning for engineering evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
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Manufacturer Narrative
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The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number have been identified.Should the device be returned at a later date, the investigation will be reopened.
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Search Alerts/Recalls
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