|
Catalog Number VDA100166 |
Device Problem
Material Rupture (1546)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/08/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during an angioplasty procedure, the balloon allegedly burst when inflated at 16 atm post dilating a stent.The procedure was completed using another device.There was no reported patient injury.
|
|
Manufacturer Narrative
|
H10: 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.H10: d4 (expiry date: 06/2026).H11:section a through f - the information provided by bd represents all of 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.H3 other text : device pending return.
|
|
Manufacturer Narrative
|
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one vida ptv dilation catheter was returned for evaluation.No specific anomalies were noted during the visual evaluation.On functional testing, the returned catheter was inflated with an in-house presto inflation device and water was leaking from the pin-hole balloon rupture.No other functional testing was performed.As a pinhole rupture was noted on the returned device during the microscopic observation, the investigation is confirmed for the reported balloon rupture.A definitive root cause for the reported balloon rupture 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: d4 (expiration date: 06/2026), g3.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.
|
|
Event Description
|
It was reported that during an angioplasty procedure via the iliac vein access, the balloon allegedly had a pinhole rupture at 16 atm post dilating a stent on the third inflation attempt.The procedure was completed using another device.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|