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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 H7493892815200
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2016
Event Type  malfunction  
Manufacturer Narrative
Age at the time of event: 18 years or older. (b)(4). Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter. The balloon was loosely folded. There was contrast in the inflation lumen. The outer shaft, inner shaft, balloon and tip were microscopically examined. A circumferential tear was identified in the balloon wall. There was a hypotube kink 63. 5cm from the tip. Inspection of the remainder of the device presented no other damage or irregularities. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. 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 device analysis completed on 08-nov-2016. It was reported that shaft kink occurred. The 75% stenosed, 13mm in length, 1. 3mm in diameter target lesion was located in the left anterior descending artery. A 2. 00mmx15mm maverick²¿ balloon catheter was advanced to the lesion. However, during delivery, the shaft was kinked 15cm from the physician. The procedure was completed with another of the same device.   no patient complications were reported and the patient's status was stable. However, returned device analysis revealed a circumferential balloon tear.
 
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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 Key6134546
MDR Text Key61100514
Report Number2134265-2016-10668
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCN
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 11/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Model NumberH7493892815200
Device Catalogue Number38928-1520
Device Lot Number19192609
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2016
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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