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

Model Number 7590

Device Problems Material Rupture (1546); Material Deformation (2976)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in severely tortuous and severely calcified mid left anterior descending artery.A 2.00mm x 20mm maverick 2 balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.A kinked was also noted due to angulation when crossing the lesion.There were no fragments left inside the patient.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Event Description

It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in severely tortuous and severely calcified mid left anterior descending artery.A 2.00mm x 20mm maverick 2 balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.A kinked was also noted due to angulation when crossing the lesion.There were no fragments left inside the patient.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that there was no kink noted as previously reported but only a significant lesion bend.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a maverick 2mr balloon catheter.The device was microscopically and visually examined.There was blood and contrast in the inflation lumen and balloon.There was blood in the guidewire lumen and the balloon was loosely folded.The device was soaked for a period of time to soften the blood and contrast in the device.The device was then prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole in the balloon located 24mm from the tip of the device.The device failed to inflate to rbp.Product analysis confirmed the reported event, as during functional testing the device was found to have a pinhole damage to the balloon.B5- describe event or problem updated.

Event Description

It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in severely tortuous and severely calcified mid left anterior descending artery.A 2.00mm x 20mm maverick 2 balloon catheter was advanced for dilatation.However, during inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.A kinked was also noted due to angulation when crossing the lesion.There were no fragments left inside the patient.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that there was no kink noted as previously reported but only a significant lesion bend.

• 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: 13318247
• MDR Text Key: 284292197
• Report Number: 2134265-2022-00551
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: 08714729370161
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7590
• Device Catalogue Number: 7590
• Device Lot Number: 0027960326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• 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
• Patient Age: 67 YR
• Patient Sex: Female