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.Expiration date: 02/2025.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.
|
It was reported that during an angioplasty procedure in the right upper arm graft to treat thrombectomy, the pta balloon allegedly ruptured circumferentially at 10 atm.It was further reported that the balloon allegedly had difficulty in retracting thru the introducer sheath.Reportedly, the balloon came out in pieces.The device and introducer sheath was removed as one unit through open incision.The procedure was completed using same device.There was no reported patient injury.
|
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 vaccess pta dilatation catheter in two segments was returned for evaluation.One segment was noted to have a catheter with a circumferentially ruptured balloon with the inner guide wire lumen exposed.The other segment was noted as the detached and remaining portion of the balloon along with the distal tip.No other anomalies were noted during the visual evaluation.No further testing was performed due to the nature of the complaint.Therefore, the investigation was confirmed for the reported balloon rupture as the balloon was circumferentially ruptured, which was able to be observed during the visual evaluation of the returned device.The investigation was also confirmed for the reported balloon detachment as the returned device was returned in two segments with the detached balloon along with the distal tip.However, the investigation for the reported difficult to remove remains inconclusive because functional testing could not be performed due to the condition of the device returned for evaluation.A definitive root cause for the reported balloon rupture, balloon detachment 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 (expiration date: 02/2025), g3, h6 (device, method).H11: h6 (result, conclusion).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 : see h10.
|