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

Model Number	7590
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a balloon rupture and dissection occurred.The 85% stenosed target lesion was located in the proximal-mid right coronary artery.A 2.00 x 20 mm maverick was advanced for treatment.When the contrast agent was applied the balloon ruptured and a dissection was noted.The balloon was withdrawn and the procedure was completed by placing a stent.The patient was stable.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.: fg maverick 2 mr, 2.00mm x 20mm was returned for analysis.Visual, tactile, microscopic and leakage analysis was performed on the device.No issues identified with the hypotube shaft.No kinks or damages noted on the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified tears in the proximal section of the balloon.Tip showed no signs of tip damage.An attempt was then made to inflate the balloon to a rate burst pressure of 12 atm using the inflation aid, however, leaks were noted coming from the tears in the proximal section of the balloon.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that a balloon rupture and dissection occurred.The 85% stenosed target lesion was located in the proximal-mid right coronary artery.A 2.00 x 20 mm maverick was advanced for treatment.When the contrast agent was applied the balloon ruptured and a dissection was noted.The balloon was withdrawn and the procedure was completed by placing a stent.The patient was stable.

• 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 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19963268
• Report Number: 2124215-2024-49947
• Device Sequence Number: 7080418
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: 08714729370161
• 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
• Report Date (Section B): 10/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2026
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0032430615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male