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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493912412300
Device Problem Deflation Problem (1149)
Patient Problems Chest Pain (1776); ST Segment Elevation (2059)
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of the nc quantum apex balloon catheter in two pieces. The shaft, hypotube, welds, tip and balloon were microscopically and visually examined. There was contrast in the inflation lumen and balloon and blood in the guidewire lumen. The balloon was loosely folded, deflated when received, and bunched up at the distal end with the tip pulled into the balloon. There were numerous kinks throughout the hypotube and shaft of the device. There was a complete hypotube separation 8mm from the strain relief. The hypotube fracture surfaces appeared to be cut, which matches the reported information of the physician cutting the hypotube. The shaft was stretched and twisted just distal of the exit notch and majority of the distal shaft was stretched and bent/kinked. The inner shaft was buckled 3mm ¿ 8mm distal of the bi-component weld. Functional testing was performed by attaching an inflation device filled with water to the remaining distal end of the device by attaching a toughy and a stopcock to the fractured hypotube. When positive pressure was applied, the balloon would not inflate. Inspection of the inner shaft showed that the buckled inner shaft was creating a blockage causing the device not to inflate and restricting the flow of water. Inspection of the remainder of the device revealed no other damage or irregularities. No other issues were identified during the product 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 deflation failed, st segment elevation and chest pain occurred. A 3. 0mm x 12mm nc quantum ¿ apex balloon catheter was advanced to post dilate an implanted stent at 12 atmospheres with a saline contrast ratio of 50-50 contrast mix. After post-dilatation, the balloon would not deflate despite multiple attempts. Subsequently, the patient had significant st elevation and started having chest. The physician decided to break the shaft in order to release the inflation pressure and deflate the balloon, however, it remained inflated. After 5 to 7 minutes, the device was removed in an inflated state with some difficulty. No further patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon deflation failed, st segment elevation and chest pain occurred. A 3. 0mm x 12mm nc quantum ¿ apex balloon catheter was advanced to post dilate an implanted stent at 12 atmospheres with a saline contrast ratio of 50-50 contrast mix. After post-dilatation, the balloon would not deflate despite multiple attempts. Subsequently, the patient had significant st elevation and started having chest. The physician decided to break the shaft in order to release the inflation pressure and deflate the balloon, however, it remained inflated. After 5 to 7 minutes, the device was removed in an inflated state with some difficulty. No further patient complications were reported and the patient's status was fine.
 
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Brand NameNC QUANTUM APEX¿
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 Key6629778
MDR Text Key108314533
Report Number2134265-2017-05681
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/18/2020
Device Model NumberH7493912412300
Device Catalogue Number39124-1230
Device Lot Number20542998
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2017
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: 06/09/2017 Patient Sequence Number: 1
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