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

Model Number	7010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 3.0mm x 12mm quantum maverick balloon catheter, it was noted that the device was separated into two pieces.The device was never used and was replaced 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 shaft break occurred.During unpacking of a 3.0mm x 12mm quantum maverick balloon catheter, it was noted that the device was separated into two pieces.The device was never used and was replaced with another of the same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a quantum maverick balloon catheter and photo media attached.The device was visually and microscopically examined.There was a separation of the hypotube at 45.4cm from the strain relief.The separated ends of the hypotube were ovaled in shape indicating the device was kinked prior to separation.There was contrast in the inflation lumen and the balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Photo media was reviewed and found to be aligned to what was seen in product analysis as the separation was found in both analysis, and media review.Product analysis confirmed the reported break as there was separation to 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; 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: 14620341
• Report Number: 2134265-2022-05954
• Device Sequence Number: 20118957
• Product Code: LOX
• UDI-Device Identifier: 08714729392675
• UDI-Public: 08714729392675
• 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): 08/18/2022

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: 06/21/2024
• Device Model Number: 7010
• Device Catalogue Number: 7010
• Device Lot Number: 0027534661
• 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: 05/20/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• 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: 36 YR
• Patient Sex: Male
• Patient Weight: 70 KG