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

Model Number	7005
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contamination occurred.A 2.5mm x 8mm quantum maverick balloon catheter was selected for use in a percutaneous transluminal coronary angioplasty.However, during unpacking of the device, it was found that the balloon was not sealed and the sterility of the inner pouch was compromised.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that contamination occurred.A 2.5mm x 8mm quantum maverick balloon catheter was selected for use in a percutaneous transluminal coronary angioplasty.However, during unpacking of the device, it was found that the balloon was not sealed and the sterility of the inner pouch was compromised.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of the quantum maverick balloon catheter in an opened shelf box, inside a product pouch.The packaging was visually examined.The shelf box was opened with the product pouch inside with the instructions for use.The product pouch was removed from the shelf box and the product pouch was unsealed with the quantum maverick device inside pouch.The pouch was inspected and found to have not been sealed during manufacturing.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15186357
• Report Number: 2124215-2022-27638
• Device Sequence Number: 5681967
• Product Code: LOX
• UDI-Device Identifier: 08714729392545
• UDI-Public: 08714729392545
• 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): 10/11/2022

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: 09/04/2023
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0025968226
• 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: 07/20/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2020
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 62 KG