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

Model Number	7580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the femoral artery.The 80% stenosed, 24x2.50mm, concentric and de novo target lesion was located in the moderately tortuous and severely calcified distal left anterior descending artery.A 2.50mm x 12mm maverick balloon catheter was advanced for predilatation.However, during the procedure, the physician observed that the shaft of the balloon was broken.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a maverick 2 mr balloon catheter.The device was visually and microscopically examined.The shipping mandrel and balloon protector were returned in place on the device and were removed.There was contrast in the inflation lumen and balloon.There was damage to the rapid port exchange.The folds of the balloon were tight, however with balloon protector removed the proximal end of the balloon folds were slightly opened which is consistent with any slight twisting of the balloon protector during application or removal.The device was attached to an inflation device filled with water and was inflated to rated burst pressure.The device failed to inflate to rated burst pressure as there was a puncture of the guidewire lumen 2mm from the rapid port exchange.Product analysis could not confirm the reported break, as the rapid port exchange was damaged but not separated.Functional testing showed an unreported puncture to the guidewire lumen.The damage found to the device is consistent with an interaction, or difficulties removing or inserting the guidewire.
Event or Problem Description
It was reported that shaft break occurred.Vascular access was obtained via the femoral artery.The 80% stenosed, 24x2.50mm, concentric and de novo target lesion was located in the moderately tortuous and severely calcified distal left anterior descending artery.A 2.50mm x 12mm maverick balloon catheter was advanced for predilatation.However, during the procedure, the physician observed that the shaft of the balloon was broken.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.

• Brand Name: 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: 12662246
• Report Number: 2134265-2021-13028
• Device Sequence Number: 4211720
• Product Code: LOX
• UDI-Device Identifier: 08714729369981
• UDI-Public: 08714729369981
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 01/20/2022

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: 08/21/2022
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0024308658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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: 71 YR
• Patient Sex: Male