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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 H7493892809200
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. If there is any further relevant information obtained, a supplemental medwatch will be filed. (b)(4).
 
Event Description
It was reported that shaft break occurred. During preparation of a 2. 00mm x 9mm maverick²¿ balloon catheter, upon wiring the balloon, it was noted that the balloon snapped off. The device was not used inside the patient and the procedure was completed with a emerge balloon catheter. No patient complications were reported and the patient's status was good.
 
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of a maverick 2 balloon catheter in two pieces. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 91. 7cm from the hub. The fracture faces were oval as if kinked prior to separation. There are numerous hypotube and shaft kinks. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact. (b)(4).
 
Event Description
It was reported that shaft break occurred. During preparation of a 2. 00mm x 9mm maverick²¿ balloon catheter, upon wiring the balloon, it was noted that the balloon snapped off. The device was not used inside the patient and the procedure was completed with a emerge balloon catheter. No patient complications were reported and the patient's status was good.
 
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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 Key7566965
MDR Text Key110007970
Report Number2134265-2018-04872
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/02/2021
Device Model NumberH7493892809200
Device Catalogue Number38928-0920
Device Lot Number21698215
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2018
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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