BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7213 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
Event Type
malfunction
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Event Description
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It was reported that product was mislabeled.A 3.75mm x 15mm nc emerge balloon catheter was requested for use in a coronary treatment procedure.The scrub technician selected an emerge balloon catheter from a box labeled 3.75mm x 15mm nc emerge balloon catheter.The emerge balloon catheter was prepared and advanced to the lesion.Under fluoroscopy, the balloon size did not look accurate.The emerge balloon catheter was removed from the patient.Upon inspection it was observed on the manifold that the emerge was a 2.5mm x 12mm and not 3.75mm x 15mm as labeled.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of packaging to an nc emerge balloon catheter, outer box, product pouch, and protective hoop.The device returned was an emerge balloon catheter.The product pouch was visually inspected.The product pouch contained a unit for batch 25904100.The batch number on the returned packaging was 25911565.The tyvek seal was inspected, and it was pulled open on the back flap of the packaging.The batches to these devices were run simultaneously and at the same packaging station.The device was microscopically and visually examined.There was contrast present in the inflation lumen and the balloon folds.The balloon was tightly folded.Inspection of the remainder of the packaging and device presented no other damage or irregularities.Product analysis found the device was not compatible with the packaging returned.
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Event Description
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It was reported that product was mislabeled.A 3.75mm x 15mm nc emerge balloon catheter was requested for use in a coronary treatment procedure.The scrub technician selected an emerge balloon catheter from a box labeled 3.75mm x 15mm nc emerge balloon catheter.The emerge balloon catheter was prepared and advanced to the lesion.Under fluoroscopy, the balloon size did not look accurate.The emerge balloon catheter was removed from the patient.Upon inspection it was observed on the manifold that the emerge was a 2.5mm x 12mm and not 3.75mm x 15mm as labeled.The procedure was completed with a different device.No patient complications were reported.
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Search Alerts/Recalls
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