Model Number 23375 |
Device Problems
Leak/Splash (1354); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter address 1: (b)(6).
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Event Description
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It was reported that balloon rupture and leak occurred.On (b)(6) 2020, a balloon dilation on the esophagus using an 18-4/5.8/120 xxl balloon dilator was prepared for the procedure.During preparation, a leak test on the catheter noted that the balloon was leaking air.However, a video was provided that showed that a pinhole was found on the balloon, which contributed to the leak where liquid was coming off.The device was removed and replaced for a different model to complete the procedure.There were no patient complications reported.
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Event Description
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It was reported that balloon rupture and leak occurred.On (b)(6) 2020, a balloon dilation on the esophagus using an 18-4/5.8/120 xxl balloon dilator was prepared for the procedure.During preparation, a leak test on the catheter noted that the balloon was leaking air.However, a video was provided that showed that a pinhole was found on the balloon, which contributed to the leak where liquid was coming off.The device was removed and replaced for a different model to complete the procedure.There were no patient complications reported.
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Manufacturer Narrative
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E1: initial reporter address 1: (b)(4).Device was not returned to the manufacturer; however, medial from the clinical procedure was provided to boston scientific and reviewed by a member of bsc cis.A copy of the media review report was attached to the record.The media review report concluded: a video showed that the balloon was inflated, and a pinhole leak was noted on the balloon material.
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Search Alerts/Recalls
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