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

Model Number	7005
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The device was visually and microscopically examined.There was a hypotube kink at 56cm from the strain relief.There was a separation in the hypotube at 87.5cm from the strain relief.The separated ends of the hypotube were oval shaped indicating that the device was kinked prior to separation.There was contrast in the inflation lumen.The rapid port exchange was damaged, and the balloon was tightly folded with blood and contrast present in the balloon folds.Photo reviewed depicted separation to the device which aligns to the separation found in product analysis.The damage to the device is consistent to what can occur during the procedure or an interaction with patient characteristics.
Event or Problem Description
Reportable based on device analysis completed on 01-mar-2022.It was reported that the device was damaged.A 3.5mm x 8mm quantum maverick balloon catheter was selected for use.However, after unpacking, it was found that the device was damaged and could not be used.No patient complications were reported and the patient status was stable.However, device analysis revealed a hypotube separation.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13895242
• Report Number: 2134265-2022-02395
• Device Sequence Number: 4470013
• Product Code: LOX
• UDI-Device Identifier: 08714729392583
• UDI-Public: 08714729392583
• 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
• Report Date (Section B): 03/24/2022

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: 09/23/2023
• Device Model Number: 7005
• Device Catalogue Number: 7005
• Device Lot Number: 0026063225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2020
• 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: 54 YR
• Patient Sex: Male