Model Number 9004 |
Device Problems
Material Rupture (1546); Failure to Advance (2524); Device-Device Incompatibility (2919); Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/06/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during an angioplasty procedure, the drug coated balloon was allegedly unable to be advanced to the target lesion.It was further reported that the drug coated balloon allegedly stuck on the wire.Reportedly, upon removal of the device, it was found that the balloon allegedly snagged on the catheter and looked like it was starting to elongate.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.(expiry date: 11/2023).Device pending return.
|
|
Manufacturer Narrative
|
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiry date: 11/2023).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.
|
|
Event Description
|
It was reported that during an angioplasty procedure, the drug coated balloon was allegedly unable to be advanced to the target lesion.It was further reported that the drug coated balloon allegedly stuck on the wire.Reportedly, upon removal of the device, it was found that the balloon allegedly snagged on the catheter and looked like it was starting to elongate.There was no reported patient injury.
|
|
Search Alerts/Recalls
|