Model Number B1070-080 |
Device Problem
Difficult to Remove (1528)
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Patient Problem
Aneurysm (1708)
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Event Date 01/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that this was a procedure to treat thrombosis in the left arteriovenous (av) fistula.An armada balloon catheter was inserted, and angioplasty was performed.However, after angioplasty was performed, angiogram showed residual thrombus and an aneurysm of the av fistula.A high-grade stenosis of the av fistula was also noted.During removal of the balloon catheter, the physician stated that due to patient anatomy, the device was difficult to remove.The balloon catheter was able to be removed without causing damage to the patient.To further treat the stenosed area, a non-abbott device was successfully used.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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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 identified no other similar incidents reported from this lot.The investigation determined that anatomical conditions were the likely cause for the reported difficulties to remove.The reported aneurysm is also caused by case circumstances.The reported patient effect of aneurysm as listed in the instructions for use, states: the following complications may occur as a result of percutaneous transluminal angioplasty (pta) but may not be limited to: aneurysm or pseudoaneurysm in vessel, or at vascular access site.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
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Manufacturer Narrative
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The device was returned for analysis.The reported difficulty to remove could not be tested based on the condition of the device.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 identified no other similar incidents reported from this lot.The investigation determined that anatomical conditions were the likely cause for the reported difficulties to remove.The reported aneurysm is also caused by case circumstances.The reported patient effect of aneurysm is listed in the instructions for use as a potential procedural complication.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4: lot number updated from 01016g2 to 01016g1.D9: the device has been received.H6: type of investigation code 4114, removed.H6: type of investigation code 10, added.
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Search Alerts/Recalls
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