BOSTON SCIENTIFIC CORPORATION SYMMETRY STIFF SHAFT; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 23335 |
Device Problem
Material Rupture (1546)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified arteriovenous anastomosis.Two 4.0-10/4t/90 symmetry stiff shaft balloon catheters were advanced for dilatation.However, during the initial inflation at 12 atmospheres, the balloons ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
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Manufacturer Narrative
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E1 - initial reported address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure for 30 seconds without issue.A vacuum was then applied.The inflation device was verified before and after use.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from damage.No issues were noted which may have potentially contributed to the complaint incident.No issues were identified during the product analysis.
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Event Description
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It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified arteriovenous anastomosis.Two 4.0-10/4t/90 symmetry stiff shaft balloon catheters were advanced for dilatation.However, during the initial inflation at 12 atmospheres, the balloons ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
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