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	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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 "3.0/6 inside 2.75 box" 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.
Event or Problem Description
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.

• 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: 13862800
• Report Number: 2134265-2022-03281
• Device Sequence Number: 20006707
• Product Code: NWX
• UDI-Device Identifier: 08714729888161
• UDI-Public: 08714729888161
• 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): 04/17/2022

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: 09/15/2023
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0028023060
• 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): Follow-Up
• Initial Date Received by Manufacturer: 03/02/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 04/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown