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

Model Number	7580
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the proximal to mid segment of right coronary artery.After a 6f non-bsc guide catheter was in place and a non-bsc guidewire crossed the lesion, a 3.50mm x 12mm maverick balloon catheter was advanced for pre-dilation.However, during inflation, the balloon ruptured.The procedure was completed using a different balloon and a stent was deployed following post dilation.There were no patient complications reported and the patient condition was stable.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by mfr.: returned product consisted of a maverick 2mr balloon catheter.The device was visually and microscopically examined.At 31cm from strain relief, the hypotube was kinked.There was contrast and blood present in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon was loosely folded.At 8mm from the tip of the device, the balloon had a 14mm longitudinal tear.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the proximal to mid segment of right coronary artery.After a 6f non-bsc guide catheter was in place and a non-bsc guidewire crossed the lesion, a 3.50mm x 12mm maverick balloon catheter was advanced for pre-dilation.However, during inflation, the balloon ruptured.The procedure was completed using a different balloon and a stent was deployed following post dilation.There were no patient complications reported and the patient condition 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: 12842426
• Report Number: 2134265-2021-14584
• Device Sequence Number: 4351835
• Product Code: LOX
• UDI-Device Identifier: 08714729370024
• UDI-Public: 08714729370024
• 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): 01/31/2022

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: 12/09/2021
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0023056260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 6F JR 4; GUIDE CATHETER: 6F JR 4; GUIDE WIRE: RUNTHROUGH NS; GUIDE WIRE: RUNTHROUGH NS
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 65 KG