MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number	3853
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 - 2.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 # 27921814-100; 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 or Problem Description
It was reported that a labeling issue occurred.While outside the patient, during preparation of a 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.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13840279
• Report Number: 2134265-2022-02998
• Device Sequence Number: 11750303
• Product Code: NWX
• UDI-Device Identifier: 08714729888178
• UDI-Public: 08714729888178
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0028056142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown