BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
|
Back to Search Results |
|
Model Number CQ7584 |
Device Problems
Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/21/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date: 10/2023.
|
|
Event Description
|
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate and deflate.The procedure was completed using another device.There was no reported patient injury.
|
|
Event Description
|
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate and deflate.The procedure was completed using another device.There was no reported patient injury.
|
|
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: 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 inflation, deflation issue and difficult to remove could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 10/2023), g3, h6(device, method).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.
|
|
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 conquest pta dilatation catheter has been received for the evaluation.On the visual evaluation, the device was noted to be bloody and no other specific anomalies were noted.On the functional evaluation, the balloon was inflated to 8 atm using an in-house presto inflation device and the balloon was maintained the pressure without any issue.Further, the balloon was deflated and it takes the deflation time of 27 seconds which is below the maximum deflation time in the product performance specification limit.Balloon was cut and the port holes were noted to be collapsed and the glue bullet was not seated in the correct position.No other functional testing performed.Under the microscopic observation, all the anomalies were noted.Therefore the investigation for the reported inflation issue was unconfirmed, as the balloon was successfully inflated during the functional evaluation.The investigation for the identified deflation issue was also unconfirmed, as the balloon was deflated successfully and the deflation time was also noted to be below the maximum deflation time in the product performance limit.The investigation for the reported difficult to remove remains inconclusive, as the functional testing was not performed.A definitive root cause for the reported inflation, deflation issue and difficult to remove could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiry date: 10/2023), g3.H11: h6 (method).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.H3 other text : see h10.
|
|
Event Description
|
It was reported that during an angioplasty procedure, the pta balloon allegedly failed to inflate and deflate.It was further reported that the device was allegedly difficult to remove.The procedure was completed using another device.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|