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

Model Number 7580

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  malfunction  

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 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
• Type of Device: 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: 12025335
• MDR Text Key: 257223982
• Report Number: 2134265-2021-07832
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729369967
• UDI-Public: 08714729369967
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1