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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely calcified coronary artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilation.However, during the procedure, the balloon burst.Subsequently, post-dilatation was performed with a 2.5 x 12 balloon catheter, and a 2.5 x 19 promus premier drug-eluting stent was used, but a large resistance was noted, and it failed to cross the lesion.After withdrawal, it was found that the surface of the stent was not smooth and could not be used normally.The procedure was completed with another of the same device.No patient complications were reported, and the patient's status was stable.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).Device evaluated by mfr: returned product consisted of a maverick 2mr balloon catheter.A visual inspection revealed a kink to both the shaft and hypotube 5mm proximal from the rapid port exchange.The rapid port exchange was damaged.The device was returned with the mandrel in place which was able to be removed without issue or resistance.A microscopic inspection revealed that the proximal markerband appeared shifted into the proximal cone.Operations engineering reviewed the applicable manufacturing records related to the complaint device.There is no indication that the reported complaint is related to the manufacturing process.A functional test revealed that the device was prepped with an inflation device filled with water and connected to the calibrated pressure gage to inflate the device.The device inflated to rated burst pressure and deflated with no issue.Media depicts device within shipping hoop with no damage detected.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the severely calcified coronary artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilation.However, during the procedure, the balloon burst.Subsequently, post-dilatation was performed with a 2.5 x 12 balloon catheter, and a 2.5 x 19 promus premier drug-eluting stent was used, but a large resistance was noted, and it failed to cross the lesion.After withdrawal, it was found that the surface of the stent was not smooth and could not be used normally.The procedure was completed with another of the same device.No patient complications were reported, and the patient's status 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: 18677388
• Report Number: 2124215-2024-07488
• Device Sequence Number: 15001381
• 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): 04/22/2024

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 Expiration Date: 02/26/2026
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0031124527
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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 Sex: Unknown