BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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Model Number 3853 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that a labeling issue occurred.A 6mmx2.75mm wolverine coronary cutting balloon was selected for use.During preparation, upon opening the sealed box, it was noted that a 3.0mm x 6mm wolverine was inside the box.The procedure was completed with another device.No patient complications were reported.
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Event Description
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It was reported that a labeling issue occurred.A 6mmx2.75mm wolverine coronary cutting balloon was selected for use.During preparation, upon opening the sealed box, it was noted that a 3.0mm x 6mm wolverine was inside the box.The procedure was completed with another device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for evaluation.Received for analysis was an open shelf carton labelled for a wolverine cb mr, us 6mmx2.75mm; batch # 28023060 upn: h74939401062750 use by : 2023 - 09 - 15.The closure strip was torn open which indicates that the box carton had been opened.No damage was observed with the shelf carton however there was a handwritten "wrong balloon in package" message in black across the carton label.Inside the carton was an opened tyvek pouch which was labelled for a wolverine 6mmx3.0mm; lot # 27968750-027; batch # 28156142 upn: h74939401063000 use by: 2023 - 09 - 2.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.
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