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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE QUANTUM¿ MAVERICK¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493808012270
Device Problems Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problems Death (1802); Perforation of Vessels (2135); Cardiac Tamponade (2226); Cardiogenic Shock (2262)
Event Date 11/22/2017
Event Type  Death  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the hypotube and hub of the quantum maverick balloon catheter. The midshaft had separated from the bond 107. 5cm from the hub. The midshaft material was jagged which indicates the separation was due to tensile overload. The distal end of the device was not returned for analysis. There were numerous hypotube kinks. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The reported information indicates the device was inflated to 20atm; therefore, there is no indication the device was inflated over rated burst pressure (rbp). The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
Same case as mfr report#: 2134265-2017-12668. It was reported that removal difficulty, balloon burst and detachment occurred, and the patient had coronary perforation, pericardial tamponade, cardiogenic shock, and expired. The 80% stenosed target lesion was located in the highly calcified medial ramus interventricularis anterior (riva). A 2. 5x12mm promus premier select drug-eluting stent was implanted in the target lesion without problems. During post-dilation with a 2. 75x12mm quantum maverick balloon at 20 bar, the balloon burst. The balloon was pulled back with resistance and was torn off the shaft. Angiography identified the two x ray markers of the balloon in the riva. There was a coronary perforation with pericardial tamponade and cardiogenic shock. After trying all interventional options and 2 hours of resuscitation, the patient expired.
 
Manufacturer Narrative
Method and conclusion codes updated. Device analysis summary (below) corrected. Device evaluated by mfr. : the manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The dfu indicates; "do not exceed the rated balloon burst pressure. " the balloon was reportedly inflated to 20 atm, the dfu lists 18 atm as the stent rated burst pressure for 2. 75 mm diameter devices. The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user. (b)(4).
 
Event Description
It was reported that removal difficulty, balloon burst and detachment occurred, and the patient had coronary perforation, pericardial tamponade, cardiogenic shock, and expired. The 80% stenosed target lesion was located in the highly calcified medial ramus interventricularis anterior (riva). A 2. 5x12mm promus premier select drug-eluting stent was implanted in the target lesion without problems. During post-dilation with a 2. 75x12mm quantum maverick balloon at 20 bar, the balloon burst. The balloon was pulled back with resistance and was torn off the shaft. Angiography identified the two x ray markers of the balloon in the riva. There was a coronary perforation with pericardial tamponade and cardiogenic shock. After trying all interventional options and 2 hours of resuscitation, the patient expired.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Same case as mfr report#: 2134265-2017-12668. It was reported that removal difficulty, balloon burst and detachment occurred, and the patient had coronary perforation, pericardial tamponade, cardiogenic shock, and expired. The 80% stenosed target lesion was located in the highly calcified medial ramus interventricularis anterior (riva). A 2. 5 x 12 mm promus premier select drug-eluting stent was implanted in the target lesion without problems. During post-dilation with a 2. 75 x 12 mm quantum maverick balloon at 20 bar, the balloon burst. The balloon was pulled back with resistance and was torn off the shaft. Angiography identified the two x ray markers of the balloon in the riva. There was a coronary perforation with pericardial tamponade and cardiogenic shock. After trying all interventional options and 2 hours of resuscitation, the patient expired.
 
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Brand NameQUANTUM¿ MAVERICK¿
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 Key7135662
MDR Text Key105945661
Report Number2134265-2017-12646
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
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,Followup
Report Date 12/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Model NumberH7493808012270
Device Catalogue Number38080-1227
Device Lot Number20251518
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2017 Patient Sequence Number: 1
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