|
Catalog Number CQF5074 |
Device Problems
Difficult to Remove (1528); Material Rupture (1546)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/09/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured during dilation.The procedure was completed using another device.There was no reported patient injury.
|
|
Manufacturer Narrative
|
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiration date: 05/2025) the information provided 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.
|
|
Event Description
|
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured during dilation.Further it was reported that the balloon felt resistance when retrieving through the sheath but was removed as one unit.The procedure was completed using another balloon.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported balloon rupture and difficult to remove from sheath could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiration date: 05/2025), g3, h6 (device, method).H11: section a through f ¿ the information provided 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.
|
|
Search Alerts/Recalls
|
|
|