Catalog Number 48522050 |
Device Problems
Inflation Problem (1310); Material Rupture (1546); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images and videos were provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the savvy long pta dilatation catheter products that are cleared in the us.The pro code and 510 k number for the savvy long pta dilatation catheter products are identified.(expiry date: 01/2023).
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Event Description
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It was reported that during an angioplasty procedure, the balloon allegedly ruptured in the middle portion.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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H10: the file was reassessed for reportability and determined to be not-reportable.H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending; however, images and videos were provided for review.The investigation of the reported event is currently underway.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the savvy long pta dilatation catheter products that are cleared in the us.The pro code and 510 k number for the savvy long pta dilatation catheter products are identified in d2 and g5.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that during an angioplasty procedure through superficial femoral artery, there was an alleged inflation issue and balloon torsion noted at 6atm.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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