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

Model Number	7580
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending.After a 6f non-bsc guide catheter and a non-bsc guidewire were crossed the lesion, a 2.00mm x 12mm maverick balloon catheter was advanced for pre-dilatation.However, during the procedure, it failed to cross the lesion due to calcification and when inflated at 10 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a 2.0x12mm non-bsc balloon.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending.After a 6f non-bsc guide catheter and a non-bsc guidewire were crossed the lesion, a 2.00mm x 12mm maverick balloon catheter was advanced for pre-dilatation.However, during the procedure, it failed to cross the lesion due to calcification and when inflated at 10 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a 2.0x12mm non-bsc balloon.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an incomplete maverick 2mr balloon catheter.The device was visually and microscopically examined.There was contrast present in the inflation lumen and balloon.There was blood in the inflation lumen.At proximal to the proximal balloon waist, for a length, the inflation lumen was buckled.This damage is indicative to removal or advancement difficulties.The balloon was returned loosely folded.At the distal waist moving proximally for a length of, the balloon has a longitudinal tear.The tip segment was found to be slightly stretched and the most distal portion (pink) was found to be detached and failed to return with the device.Product analysis confirmed the reported burst, as the balloon was found to have a longitudinal tear.The reported failure to cross the lesion could not be confirmed as the clinical circumstances could not be replicated.There were unreported damages to the device consistent to damage that would cause resistance or advancement to the device such as a buckled inflation lumen, and a stretched and detached tip.E1: initial reporter address 1: (b)(6) hospital.

• 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: 16116067
• Report Number: 2124215-2022-55494
• Device Sequence Number: 6839643
• Product Code: LOX
• UDI-Device Identifier: 08714729369967
• UDI-Public: 08714729369967
• 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): 03/01/2023

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: 06/01/2025
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0029515932
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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: Male
• Patient Race: Asian