BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
|
Back to Search Results |
|
Model Number CQF75104 |
Device Problems
Material Frayed (1262); Peeled/Delaminated (1454); Material Rupture (1546)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/27/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
|
|
Event Description
|
It was reported that during an angioplasty procedure the pta balloon allegedly was unable to inflate at the lesion site.The balloon was removed successfully from the patient without issue, the health care provider allegedly found a pinhole rupture during testing on the back table.It was further reported that another balloon was used to complete the procedure.There was no reported retraction issue, detachment of balloon material, nor any vessel damage.There was no reported patient injury.
|
|
Manufacturer Narrative
|
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was returned for evaluation.A visual inspection found the outer layer peeling and fiber disturbance on the balloon.The device was inflated, and a pinhole rupture was noted at the location of the peeled outer layer.Therefore, the investigation is confirmed for outer layer peeling, fiber disturbance, and for a pinhole rupture.The root cause for the reported rupture or identified fiber and outer layer issues could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.The information provided by bard 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 bard.
|
|
Event Description
|
It was reported that during an angioplasty procedure the pta balloon allegedly was unable to inflate at the lesion site.The balloon was removed successfully from the patient without issue, the health care provider allegedly found a pinhole rupture during testing on the back table.It was further reported that another balloon was used to complete the procedure.There was no reported retraction issue, detachment of balloon material, nor any vessel damage.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|