BOSTON SCIENTIFIC CORPORATION RENEGADE HI-FLO FATHOM SYSTEM; CATHETER, CONTINUOUS FLUSH
|
Back to Search Results |
|
Model Number 29462 |
Device Problems
Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/28/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the microcatheter pulled apart and the outer coating split.A fathom 16 180cm renhf 150cm 10 preload renegade hi flo microcatheter system was selected for use.During the procedure, it was noted that the device was getting stuck within the diagnostic catheter.A tight push was needed, and the device was able to be advanced for treatment.When the device was pulled out and checked, the microcatheter pulled apart and stretched.The coating layer split and separated.The device was removed from the patient intact, and the procedure was completed.The patient was not harmed, and no complications were reported.
|
|
Manufacturer Narrative
|
Device evaluated by mfr: the device was returned for evaluation.The hub and the part of the shaft that was visible was inspected for damage.The renegade device was stuck in the angiographic catheter.A touhey was attached to a 4fr.038 angio catheter.The shaft of the renegade was kinked 12.5cm from the tip and protruding from the angio catheter 12.5cm.There was stretching located 5cm, 8.5cm, 18cm, and 23cm from the hub.No fractures were noticed on the shaft.The coating issue the customer stated is most likely the shaft damage that was confirmed, no coating issues were confirmed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for inserting issues and shaft damage.
|
|
Event Description
|
It was reported that the microcatheter pulled apart and the outer coating split.A fathom 16 180cm renhf 150cm 10 preload renegade hi flo microcatheter system was selected for use.During the procedure, it was noted that the device was getting stuck within the diagnostic catheter.A tight push was needed, and the device was able to be advanced for treatment.When the device was pulled out and checked, the microcatheter pulled apart and stretched.The coating layer split and separated.The device was removed from the patient intact, and the procedure was completed.The patient was not harmed, and no complications were reported.
|
|
Search Alerts/Recalls
|
|
|