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

Model Number	7015
Medical Device Problem Codes	Contamination (1120); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device inner package was compromised.A 3.0mm x 15mm quantum maverick balloon catheter selected for use.However, after opening the outer package, it was noticed that the sticking place of the inner package was opened and exposed to air.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that device contamination might occurred.The target lesion was located in the left anterior descending artery.A 3.0mm x 15mm quantum maverick balloon catheter was advanced for dillatation.However, the device inner package was opened and exposed to air.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device codes corrected.The returned product consisted of an nc emerge balloon catheter and its tyvek inner packaging.No outer box was returned.Photo media was also provided.The product pouch and tyvek seal were visually inspected.The bottom tyvek (white) seal was pulled and curled up on the back flap of the packaging far enough that the device was elementally exposed.However, all seals on the package were complete and sealed at one point without error.Inspection of the remainder of the device, apart from the observed damage to packaging, revealed no other damage or irregularities.Photo media was reviewed and found to match analysis of the device.

• 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 johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12556747
• Report Number: 2134265-2021-11803
• Device Sequence Number: 11634879
• Product Code: LOX
• UDI-Device Identifier: 08714729392781
• UDI-Public: 08714729392781
• 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): 11/22/2021

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: 10/29/2023
• Device Model Number: 7015
• Device Catalogue Number: 7015
• Device Lot Number: 0026266770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG