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

Model Number	7590
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.Upon unpacking of a 2.50mm x 20mm maverick balloon catheter, it was noted that the shaft was damaged and broken.The procedure was completed with another of the same device.No patient complications were reported and patient was stable.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that shaft break occurred.Upon unpacking of a 2.50mm x 20mm maverick balloon catheter, it was noted that the shaft was damaged and broken.The procedure was completed with another of the same device.No patient complications were reported, and patient was stable.It was further reported that rapid exchange part of the balloon was found to be fractured after being unpacked.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.H6 device code changed from "break" to "material split, cut or torn".E1: initial reporter phone: (b)(6).E1: initial reporter facility name: (b)(6) university.
Additional Manufacturer Narrative
H6: device codes: corrected from "material split, cut or torn" to "break".B5: describe event or problem: updated to include new information obtained.E1: initial reporter phone: (b)(6).E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: returned product consisted of a maverick 2mr balloon catheter.Visual inspection revealed no damage or irregularity.The device was returned with a stylet and balloon protector in place which were both removed without issue or irregularity.Microscopic inspection revealed no damage or irregularity.There is no sign of fluid to the device and the balloon was tightly folded.Media inspection depicts a portion of the device within and out of its shipping hoop; however, due to visibility it is unclear if the visible portion is a separation or a portion of the device with the shipping mandrel visible.Therefore, the media provided is found to be inconclusive.
Event or Problem Description
It was reported that shaft break occurred.Upon unpacking of a 2.50mm x 20mm maverick balloon catheter, it was noted that the shaft was damaged and broken.The procedure was completed with another of the same device.No patient complications were reported, and patient was stable.It was further reported that rapid exchange part of the balloon was found to be fractured after being unpacked.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19137760
• Report Number: 2124215-2024-22038
• Device Sequence Number: 8501621
• Product Code: LOX
• UDI-Device Identifier: 08714729370185
• UDI-Public: 08714729370185
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2024

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 Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0032713421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 05/31/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/03/2024; 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 55 KG