Model Number H7493902416350 |
Device Problems
Hole In Material (1293); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/09/2016 |
Event Type
Injury
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Manufacturer Narrative
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Device is a combination product.(b)(4).
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Event Description
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It was reported that stent inadequate apposition and balloon pinhole occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery (mid rca).A 16mm x 3.50mm ion drug-eluting stent was selected for used and advanced to treat the target lesion.Upon reaching the target lesion, the physician instructed the technologist assisting with the procedure to inflate the device.However, as the technologist increased the pressure on the inflation device, it was noticed that the pressure never went beyond 2 atmospheres even as more pressure was delivered.The inflation device was pulled negative and another attempt was made at inflation of the balloon and expansion of the stent in question.Again, the pressures never exceeds 2 atmospheres.The stent delivery catheter was then removed from the patient's body and a fresh 2.00 x 15 emerge mr balloon catheter was inserted and passed through the stent in question.This balloon was inflated several times to rated burst pressure (rbp) and was then withdrawn from the patient.The procedure was then completed with a fresh 3.75 x 16mm nc emerge mr balloon catheter advanced to the stented area and inflated several times to rbp along the entire length of the stent.Subsequent angiograms were then taken all displaying a excellent result with full expansion of the stented area.Outside the patient's body, when the ion was inflated, it was noted that there was a pinhole on the balloon catheter no patient complications were reported and the patient then left the catheterization laboratory pain free.
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Manufacturer Narrative
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Device evaluated by mfr.: the stent delivery system (sds) was returned for analysis.A visual and microscopic examination found that the stent had detached from the device and was not returned.The bumper tip was not damaged.There was a pinhole in the balloon material at the proximal end of the balloon.A visual and tactile examination found several hypotube kinks.A visual and tactile examination found no issue with the shaft polymer extrusion profile.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/ procedural factors.(b)(4).
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Event Description
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It was reported that stent inadequate apposition and balloon pinhole occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified mid right coronary artery (mid rca).A 16mm x 3.50mm ion drug-eluting stent was selected for used and advanced to treat the target lesion.Upon reaching the target lesion, the physician instructed the technologist assisting with the procedure to inflate the device.However, as the technologist increased the pressure on the inflation device, it was noticed that the pressure never went beyond 2 atmospheres even as more pressure was delivered.The inflation device was pulled negative and another attempt was made at inflation of the balloon and expansion of the stent in question.Again, the pressures never exceeds 2 atmospheres.The stent delivery catheter was then removed from the patient's body and a fresh 2.00 x 15 emerge mr balloon catheter was inserted and passed through the stent in question.This balloon was inflated several times to rated burst pressure (rbp) and was then withdrawn from the patient.The procedure was then completed with a fresh 3.75 x 16mm nc emerge mr balloon catheter advanced to the stented area and inflated several times to rbp along the entire length of the stent.Subsequent angiograms were then taken all displaying a excellent result with full expansion of the stented area.Outside the patient's body, when the ion⠗as inflated, it was noted that there was a pinhole on the balloon catheter no patient complications were reported and the patient then left the catheterization laboratory pain free.
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Search Alerts/Recalls
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