Model Number 7585 |
Device Problem
Material Rupture (1546)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/11/2020 |
Event Type
malfunction
|
Event Description
|
It was reported that balloon rupture occurred.The 95% stenosed, 16 mm x 3.5 mm target lesion was located in the severely calcified and severely tortuous proximal left coronary artery.A 2.50 mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation at 15 atmospheres for 20 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
|
|
Event Description
|
It was reported that balloon rupture occurred.The 95% stenosed, 16 mm x 3.5 mm target lesion was located in the severely calcified and severely tortuous proximal left coronary artery.A 2.50 mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation at 15 atmospheres for 20 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
|
|
Manufacturer Narrative
|
D4.Lot number: corrected from 24081268 to 24112976.D4.Expiration date: correction from 07/09/2022 to 07/15/2022.D4: unique identifier (udi) # corrected from (b)(4) to (b)(4).H6: device manufacture date corrected from 07/10/2019 to 07/10/2019.Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 26.5cm distal from the strain relief.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was soaked in a water bath for four days to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.
|
|
Event Description
|
It was reported that balloon rupture occurred.The 95% stenosed, 16 mm x 3.5 mm target lesion was located in the severely calcified and severely tortuous proximal left coronary artery.A 2.50 mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation at 15 atmospheres for 20 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
|
|
Manufacturer Narrative
|
D4.Lot number: corrected from 24081268 to 24112976.D4.Expiration date: correction from 07/09/2022 to 07/15/2022.D4: unique identifier (udi) # corrected from (b)(4) to (b)(4).H6: device manufacture date corrected from 07/10/2019 to 07/10/2019.
|
|
Search Alerts/Recalls
|