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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 H7493912412250
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : the returned product consisted of an nc quantum apex catheter in its original product pouch. The packaging was examined. The product pouch was received with the tyvek portion torn open. The tyvek portion is ripped. There was no damage to the device. Inspection of the remainder of the packaging and device, revealed no other damage or irregularities. No other issues were identified during the product analysis. 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 product sterility was compromised. During unpacking of a 12mm x 2. 50mm nc quantum apex¿ balloon catheter, difficulties were encountered while opening the package and the sterile pouch ripped down the middle of the sealed chevron tab, compromising the device's sterility. The device never entered the patient's body and the procedure was completed with a different balloon catheter. No patient complications were reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that product sterility was compromised. During unpacking of a 12mm x 2. 50mm nc quantum apex¿ balloon catheter, difficulties were encountered while opening the package and the sterile pouch ripped down the middle of the sealed chevron tab, compromising the device's sterility. The device never entered the patient's body and the procedure was completed with a different balloon catheter. No patient complications were reported.
 
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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 Key6995483
MDR Text Key247489055
Report Number2134265-2017-10875
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 10/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberH7493912412250
Device Catalogue Number39124-1225
Device Lot Number20139783
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2017
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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