|
Model Number 2200-3010 |
Device Problem
Deflation Problem (1149)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/02/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The patient''s dob or age at time of event, gender, weight, ethnicity, and race are unknown.This information was not available from the facility.Patient information regarding relevant tests/laboratory data or medical history are unknown.This information was not available from the facility.Report source: japan.The angiosculpt device was returned for evaluation; however, the device evaluation has not yet begun, thus a supplemental report will be filed upon completion.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
|
|
Event Description
|
The angiosculpt device was used to treat a severely calcified mid lad.During the 3rd inflation at 18 atm (rbp), contrast leaked from the guidewire exit port.An attempt was made to deflate the balloon, but unable to remove the contrast.The device was pulled through the guide catheter, but could not be retrieved due to resistance.Several attempts were made to deflate the balloon, but only able to deflate a little bit.With force applied, the device was removed from the patient.The procedure was completed with a non-angiosculpt device.No patient injury reported.This product problem is being reported due to the balloon unable to fully deflate.There is a potential for harm with recurrence.
|
|
Manufacturer Narrative
|
Block h3: the angiosculpt device was returned for evaluation.Visual inspection found no unusual characteristics of the device.During functional testing using an indeflator filled with green color dye water, the balloon was pressurized, but unable to hold pressure.A leak was observed on the distal shaft, opposite from the rx port.The balloon was able to deflate with no issues.Block h6: based on the lab analysis, the balloon deflation issue could not be confirmed.However, the shaft leak likely caused or contributed to the balloon unable to fully deflate, but the cause of the leak could not be determined.A review of the dhr and manufacturing process could not confirm a cause related to design and/or process failure.All devices are 100% leak tested during the manufacturing process.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.
|
|
Search Alerts/Recalls
|
|
|