MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION QUANTUM MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7010
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that labeling issue occurred.A 2.5mm x 12mm quantum maverick balloon catheter was selected for use.However, during unpacking, the outer package, inner package and inner shaft of the balloon, did not match the model.The size on the outer package was 2.5mm x 12mm, and the size of the inner package is 2.75mm x 12mm, but the size on the delivery shaft is still 2.5mm x 12mm.Another quantum maverick balloon catheter was used to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that labeling issue occurred.A 2.5mm x 12mm quantum maverick balloon catheter was selected for use.However, during unpacking, the outer package, inner package and inner shaft of the balloon, did not match the model.The size on the outer package was 2.5mm x 12mm, and the size of the inner package is 2.75mm x 12mm, but the size on the delivery shaft is still 2.5mm x 12mm.Another quantum maverick balloon catheter was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter within the shipping hoop and tyvek packaging and outer box.The outer box, labeled with lot batch was 27816227.The box was visually inspected and found unsealed with no other irregularity or issue.The tyvek product pouch, labeled with lot batch was 27816236 was visually inspected.The product pouch contained a unit still in the shipping hoop, for batch 27816227 and the seal was fully intact with no sign of tampering or attempt to open.Inspection of the remainder of the packaging and device presented no other damage or irregularities.Product analysis found there was a labeling issue.

• Brand Name: QUANTUM MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14578132
• Report Number: 2134265-2022-05578
• Device Sequence Number: 5078090
• Product Code: LOX
• UDI-Device Identifier: 08714729392651
• UDI-Public: 08714729392651
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 08/10/2024
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0027816227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 60 KG