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Model Number M00567340 |
Device Problems
Material Puncture/Hole (1504); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2021 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The target lesion was located in the common bile duct.A 3.00mm x 15mm nc emerge balloon catheter was advanced over the wire for dilatation.However, during the first inflation, a hole and leak was noted.A second 3.00mm x 15mm nc emerge balloon catheter was used for dilatation but the same problem was encountered.The procedure was completed with another of same device.There were no patient complications reported.
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Event Description
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It was reported that balloon rupture occurred.The target lesion was located in the common bile duct.A 3.00mm x 15mm nc emerge balloon catheter was advanced over the wire for dilatation.However, during the first inflation, a hole and leak was noted.A second 3.00mm x 15mm nc emerge balloon catheter was used for dilatation but the same problem was encountered.The procedure was completed with another of same device.There were no patient complications reported.Additional information received on 06jan2022.It was reported to boston scientific corporation that a maxforce biliary dilation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noticed that upon the first inflation there was a hole/leak and they were not able to complete the dilation.The same issue occurred with the second maxforce biliary dilation balloon.The procedure was completed with another maxforce biliary dilation balloon.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block h11: the initial report submitted on this event on (b)(6) 2021 was submitted in error, as the event does not represent an mdr-reportable scenario.
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Search Alerts/Recalls
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