Model Number 1013470-120 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2021 |
Event Type
malfunction
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Event Description
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It was reported that this was a procedure to treat a long lesion in the superficial femoral artery (sfa) with heavy calcification.An antegrade access was used in the right common femoral vein.A command guide wire successfully crossed the target lesion.Then a 6.0x150mm armada 18 balloon dilatation catheter (bdc) was advanced to the target lesion without issue; however, the balloon ruptured at 10 atmospheres during the first inflation.Therefore, the balloon was removed and the procedure continued with a 6.0x120 mm armada 18 bdc.The new armada was advanced to the target lesion without issue; however, the balloon ruptured at 4 atmospheres during the first inflation.The balloon was removed and a decision was made to laser the lesion.Then another armada bdc was successfully used to dilate the lesion.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 has returned for evaluation.The investigation has not yet been completed.A follow-up report will be submitted with all additional relevant information.The additional vascular device referenced are filed under separate medwatch report number.
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Manufacturer Narrative
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The device has returned for evaluation.The investigation has not yet been completed.A follow-up report will be submitted with all additional relevant information.The additional vascular device referenced are filed under separate medwatch report number.
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Event Description
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It was reported that this was a procedure to treat a long lesion in the superficial femoral artery (sfa) with heavy calcification.An antegrade access was used in the right common femoral vein.A command guide wire successfully crossed the target lesion.Then a 6.0x150mm armada 18 balloon dilatation catheter (bdc) was advanced to the target lesion without issue; however, the balloon ruptured at 10 atmospheres during the first inflation.Therefore, the balloon was removed and the procedure continued with a 6.0x120 mm armada 18 bdc.The new armada was advanced to the target lesion without issue; however, the balloon ruptured at 4 atmospheres during the first inflation.The balloon was removed and a decision was made to laser the lesion.Then another armada bdc was successfully used to dilate the lesion.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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Visual inspection was performed on the returned device.The reported balloon rupture was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation determined the reported balloon rupture appears to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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Event Description
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N/a.
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Search Alerts/Recalls
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