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.
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 "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.

• 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: 13862946
• Report Number: 2134265-2022-03280
• Device Sequence Number: 12086318
• 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): 04/13/2022

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: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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