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

Model Number 7585

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 95% stenosed, 16 mm x 3.5 mm target lesion was located in the severely calcified and severely tortuous proximal left coronary artery.A 2.50 mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation at 15 atmospheres for 20 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that balloon rupture occurred.The 95% stenosed, 16 mm x 3.5 mm target lesion was located in the severely calcified and severely tortuous proximal left coronary artery.A 2.50 mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation at 15 atmospheres for 20 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

D4.Lot number: corrected from 24081268 to 24112976.D4.Expiration date: correction from 07/09/2022 to 07/15/2022.D4: unique identifier (udi) # corrected from (b)(4) to (b)(4).H6: device manufacture date corrected from 07/10/2019 to 07/10/2019.Device evaluated by mfr.: returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was a kink 26.5cm distal from the strain relief.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was soaked in a water bath for four days to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that balloon rupture occurred.The 95% stenosed, 16 mm x 3.5 mm target lesion was located in the severely calcified and severely tortuous proximal left coronary artery.A 2.50 mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation at 15 atmospheres for 20 seconds, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

D4.Lot number: corrected from 24081268 to 24112976.D4.Expiration date: correction from 07/09/2022 to 07/15/2022.D4: unique identifier (udi) # corrected from (b)(4) to (b)(4).H6: device manufacture date corrected from 07/10/2019 to 07/10/2019.

• Brand Name: MAVERICK
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11013135
• MDR Text Key: 221763230
• Report Number: 2134265-2020-17817
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370086
• UDI-Public: 08714729370086
• Combination Product (y/n): N
• PMA/PMN Number: P860019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0024112976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 48