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

Model Number	7580
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in moderately tortuous and moderately calcified obtuse marginal artery.A 2.50mm x 12mm maverick 2 balloon catheter was advanced for dilatation.However, during the procedure, resistance was encountered and the shaft was broken 10-15 centimeters from the hub.The device was pulled intact from the patient's body and the procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in moderately tortuous and moderately calcified obtuse marginal artery.A 2.50mm x 12mm maverick 2 balloon catheter was advanced for dilatation.However, during the procedure, resistance was encountered and the shaft was broken 10-15 centimeters from the hub.The device was pulled intact from the patient's body and the procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an incomplete device return of a maverick 2 mr balloon catheter.Photo media was attached in complaint record.The device was microscopically and visually examined.There were numerous hypotube kinks to the returned portion of the device.At 52.1cm from the strain relief the hypotube was separated, which was also the length of the device returned.The separated end was ovaled in shape indicating the device was kinked prior to separation.No further damages were found.Review of the photo attached in the complaint record depicted a hypotube separation.Two segments were shown, and one segment had a kink visible nearest the separation point to the hypotube.The photo aligns to the reported events.Product analysis confirmed the reported events as there were numerous hypotube kinks and separation to the device contributing to the reported advancing difficulty.The damage to the device is consistent to damage that can occur during preparation, use during the procedure, or post procedure.The media provided was able to confirm the reported events.

• 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; 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: 15241405
• Report Number: 2124215-2022-28448
• Device Sequence Number: 4785463
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: 12/01/2024
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0028485042
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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: 72 YR
• Patient Sex: Male
• Patient Race: Asian