Catalog Number B2060-100 |
Device Problems
Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
|
Patient Problems
No Consequences Or Impact To Patient (2199); Claudication (2550)
|
Event Date 11/15/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
|
|
Event Description
|
It was reported that the procedure was to treat a lesion located in the right mid-superficial femoral artery (sfa) that was moderately tortuous, moderately calcified and 68% stenosed.During the first inflation, the armada 35 6 mm/100 mm ruptured between 14-16 atmospheres.There was difficulty removing the balloon catheter across the aorto-iliac bifurcation into the left iliac, as it was tortuous and calcified and a balloon fragment became stuck on the non-abbott guide wire and could not advance over the guide wire.Force was applied to withdraw the guide wire and balloon into the 6f sheath to attempt to completely encase the fractured balloon inside the sheath.Cut-down was performed in the left groin and the distal balloon marker was removed.A left lower extremity angiogram was performed to mid-sfa to confirm no foreign body occlusion.Post foreign body removal straight shots were performed, excellent doppler flow in foot confirmed post-op.There were no clinically significant delay or adverse patient sequelae.No additional information was provided.
|
|
Manufacturer Narrative
|
Internal file number: (b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other incidents.The investigation determined that the reported difficulties appear to be due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|
|
Manufacturer Narrative
|
Patient codes: 2550 labeled.Internal file number - (b)(4).The investigation determined that the reported patient effects appear to be due to case circumstances.Photos were received from the customer.The photos show the separated balloon material outside of the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
|
Event Description
|
Subsequent to the previously filed medwatch report, additional information received on (b)(6) 2019 stated the patient re-presented on an unknown date with claudication symptoms.Angiography was performed and it appeared that the patient had a clot.It was further diagnosed as a piece of the balloon material.A cut down procedure was performed on (b)(6) 2019 and the balloon material was removed.No additional information was provided.
|
|
Search Alerts/Recalls
|