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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 7580
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Manufacturer Narrative
The returned product consisted of a maverick 2mr balloon catheter. The device was microscopically and visually examined. There was both contrast and blood 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 help break up the contrast and blood and 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 5mm from the tip of the device near the distal markerband. There was no visible markerband damage to the device. The device failed to inflate to rated burst pressure.
 
Event Description
Reportable based on device analysis completed on (b)(6) 2021. It was reported that the device was damaged. The 70% stenosed target lesion was located in the mid left anterior descending artery. A 2. 00mm x 12mm maverick balloon catheter was selected for use. However, during unpacking, the device was noted to be damaged. The procedure was completed with another of same device. No patient complications were reported and the patient was stable. However, returned device analysis revealed the device had been inside the patient and had a balloon pinhole.
 
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Brand NameMAVERICK
Type of DeviceCATHETERS, 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 Key12415616
MDR Text Key269656623
Report Number2134265-2021-10928
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 09/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7580
Device Catalogue Number7580
Device Lot Number0025485974
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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