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

Model Number	7580
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 20-apr-2022.It was reported that advancing difficulties occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified distal right circumflex artery.A 2.00mm x 12mm maverick balloon catheter was selected for use but was having difficulties in advancing the device.The device was removed intact from the patient and the procedure was completed with a non-boston scientific balloon catheter.There were no patient complications reported.However, returned device analysis revealed shaft detach.
Additional Manufacturer Narrative
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 72.9cm from the strain relief, the hypotube was separated.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There was blood and contrast in the manifold of the device.The balloon was tightly folded.Product analysis could not confirm the reported event as the clinical circumstances could not be replicated.There was unreported separation to the hypotube of the device which is consistent to damage caused by advancing the catheter.

• 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: 14282039
• Report Number: 2134265-2022-04687
• Device Sequence Number: 17362050
• 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
• Report Date (Section B): 05/03/2022

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: 08/28/2023
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0025933174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2020
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 77 KG