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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 Problems Material Rupture (1546); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 11/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Device evaluated by mfr: the complaint device was not returned for analysis.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
It was reported that balloon rupture occurred.During preparation of a 2.00mm x 15mm maverick²¿ balloon catheter, it was noted that the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a maverick 2 balloon catheter.The balloon was loosely folded with contrast in the balloon and lumen.The balloon, markerbands, proximal bond and tip were microscopically examined.There were numerous hypotube kinks.Functional testing using an inflation device to inflate the balloon to the rated burst pressure for 5 minutes and revealed no balloon burst.Functional testing was completed using a thruway.014 guidewire, as the guidewire used in the clinical event was not returned for analysis.The thruway guidewire was advanced through the tip and guidewire exit notch.No resistance was felt and the difficulty was not confirmed.The reported balloon burst and difficulty loading wire was not confirmed via product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
 
Event Description
It was reported that balloon rupture occurred.During preparation of a 2.00mm x 15mm maverick²¿ balloon catheter, it was noted that the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
MAVERICK²¿
Type of Device
CATHETERS, 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 Key6178351
MDR Text Key62542718
Report Number2134265-2016-11658
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729370062
UDI-Public(01)08714729370062(17)20190630(10)19372303
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 Physician
Type of Report Initial,Followup
Report Date 11/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Model NumberH7493892815200
Device Catalogue Number38928-1520
Device Lot Number19372303
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2016
Initial Date FDA Received12/15/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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