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

Model Number 7585

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 1.50mm x 15mm maverick 2 balloon catheter was selected for use, however; during unpacking, it was noticed that the device was fractured.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.

Event Description

It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 1.50mm x 15mm maverick 2 balloon catheter was selected for use, however; during unpacking, it was noticed that the device was fractured.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.

Manufacturer Narrative

E1: initial reporter facility name - (b)(6).Device evaluated by mfr.: the returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 72.5cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 10521057
• MDR Text Key: 206533812
• Report Number: 2134265-2020-12203
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: 08714729370055
• 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
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: 7585
• Device Catalogue Number: 7585
• Device Lot Number: 0024774548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 83