BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
|
Back to Search Results |
|
Model Number 3853 |
Device Problem
Device Markings/Labelling Problem (2911)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/28/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that a labeling issue occurred.While outside the patient, during preparation of a percutaneous transluminal coronary angioplasty (ptca), a 3.00mm x 6mm wolverine coronary cutting balloon was selected for treatment, but the balloon inner plastic packaging was noticed to be mislabeled.It was noted that a 3.00mm x 6mm wolverine balloon appeared on the box, but the inside plastic packaging was noticed to be a 2.75mm x 6mm wolverine balloon.No damage to the package was noted.The procedure was completed with another device.No patient complications were reported in relation to this event.
|
|
Manufacturer Narrative
|
Device evaluated by manufacturer: received for analysis was an open shelf carton labelled for a wolverine cb mr, us 3.00mm x 6mm; batch # 28156142 upn: h74939401063000 use by: 2023 - 09 - 21.The closure strip was torn open which indicates that the box carton had been opened.No damage was observed with the shelf carton.Inside the carton was a sealed tyvek pouch which was labelled for a wolverine 2.75 x 6mm; lot # 27921814-113; batch # 28023060 upn: h74939401062750 use by : 2023 - 09 - 15.No issues noted with the pouch (no tears, punctures or holes in the material).The wolverine catheter was in its protective hoop within the pouch.
|
|
Event Description
|
It was reported that a labeling issue occurred.While outside the patient, during preparation of a percutaneous transluminal coronary angioplasty (ptca), a 3.00mm x 6mm wolverine coronary cutting balloon was selected for treatment, but the balloon inner plastic packaging was noticed to be mislabeled.It was noted that a 3.00mm x 6mm wolverine balloon appeared on the box, but the inside plastic packaging was noticed to be a 2.75mm x 6mm wolverine balloon.No damage to the package was noted.The procedure was completed with another device.No patient complications were reported in relation to this event.
|
|
Search Alerts/Recalls
|
|
|