BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7133 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The packaging, shaft, hypotube, tip and balloon were microscopically and visually examined.The pouch was opened along the vendor seal.There were numerous kinks.There was a complete separation at 20.3cm distal of the strain relief.There was contrast and blood in the inflation lumen, and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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Reportable based on device analysis completed on 21-jan-2021 it was reported that the packaging was damaged.A percutaneous coronary intervention was being performed.A 1.50mm x 15mm emerge balloon catheter was selected for use.However, the physician found that the package was damaged.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.
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