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

Model Number	7580
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event - above 18 years and older.Device evaluated by mfr.: returned product consisted of a maverick 2 mr balloon catheter.The device was microscopically and visually examined.At 32.8cm from the strain relief the hypotube of the device was kinked.There was a minimal amount of blood present in the guidewire lumen.The balloon was loosely folded.Spanning 14mm long into both proximal and distal balloon cone-waist transitions there was a longitudinal tear.The device presented no other damages or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2021.It was reported that balloon damage occurred.A 2.00mm x 12mm maverick balloon catheter was selected to treat a patient with coronary artery disease.It was noted that the balloon was damaged.The device was replaced with another of the same device.No patient complications were reported and the patient status was stable.However, returned device analysis revealed balloon longitudinal tear.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12025335
• Report Number: 2134265-2021-07832
• Device Sequence Number: 17210892
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2021

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: 11/09/2023
• Device Model Number: 7580
• Device Catalogue Number: 7580
• Device Lot Number: 0026324419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1