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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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BOSTON SCIENTIFIC - MAPLE GROVE MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493892812250
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/04/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : returned product consisted of a maverick 2 balloon catheter. The balloon was loosely folded with fluid in the balloon and lumen. The hypotube, distal shaft, balloon, markerbands, and tip were microscopically and tactile inspected. Inspection revealed a burst in the balloon material that was 8 mm in length and numerous kinks in the hypotube. Inspection of the remainder of the device revealed no other damage or irregularities. The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors. (b)(4).
 
Event Description
Reportable based on analysis completed on 04-oct-2017. It was reported that shaft kink occurred. Vascular access was obtained via the femoral artery. The 24x3. 0mm, de novo target lesion was located in the none tortuous and severely calcified left circumflex (lcx) artery. A 2. 50mm x 12mm maverick²¿ balloon catheter advanced for dilatation. However, during the procedure, it was noted that the balloon shaft was kinked. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was good. However, returned device analysis revealed balloon torn longitudinally.
 
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Brand NameMAVERICK²¿
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 Key6975070
MDR Text Key90780401
Report Number2134265-2017-10296
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729369981
UDI-Public08714729369981
Combination Product (y/n)N
Reporter Country CodeIN
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 10/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/07/2020
Device Model NumberH7493892812250
Device Catalogue Number38928-1225
Device Lot Number20617342
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2017
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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