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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7492062012200
Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 06/01/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: (b)(6). (b)(4). Device evaluated by mfr: the returned product consisted of a maverick otw balloon catheter and no other devices. The device was loosely folded. The hub/manifold, outer/inner shaft, and strain relief were microscopically and tactile inspected. Inspection revealed damage (cut) to the outer shaft, 9 mm from the distal end of the hub/manifold. Functional testing was performed by attaching an inflation device and drawing negative pressure, and air was coming back into the syringe. The inflation device was filled up with water, and positive pressure was applied, and water was found to be leaking from under the strain relief. When the strain relief was moved, damage (cut) was found on the outer shaft. Inspection of the remainder of the device found no other damage or irregularities. Further review of the manufacturing records for batch 20511346 will be performed. The root cause has been determined to be manufacturing related. (b)(4).
 
Event Description
Reportable based on device analysis completed on 12-jul-2017. It was reported that hub leakage occurred. During preparation of a 12 mm 2. 00 maverick balloon catheter, it was noted that a lot of air kept getting back into the syringe. The stopcocks and the syringe were switched out however the same issue was encountered. The device was not used and the procedure was completed with a different device. No patient complications were reported. When the case was done, the balloon was re-inflated and it was noted that the actual manifold was leaking. However, returned device analysis revealed a shaft hole/perforation.
 
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Brand NameMAVERICK
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6741076
MDR Text Key80948164
Report Number2134265-2017-07427
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model NumberH7492062012200
Device Catalogue Number20620-1220
Device Lot Number20511346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2017
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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