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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 H7493912412370
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/29/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : the returned product consisted of a nc quantum apex balloon catheter. The balloon was loosely folded. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube is kinked 12cm from the hub. Inspection of the device presented no damage or irregularities. The uv bond location is visible, but is within specification. Functional testing was carried out by attaching an inflation device filled with water to the hub of the complaint device, and inflating the device to rated burst pressure (rbp). The nc quantum apex device inflated and held pressure for 5 minutes without leaking. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event. (b)(4).
 
Event Description
It was reported that a shaft expansion occurred. A 12mm x 3. 75mm nc quantum apex¿ balloon catheter was selected for use to dilate the lesion. However, a "bubble on shaft" was noted. No patient complications were reported.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a shaft expansion occurred. A 12mm x 3. 75mm nc quantum apex¿ balloon catheter was selected for use to dilate the lesion. However, a "bubble on shaft" was noted. 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 Key7206181
MDR Text Key277184312
Report Number2134265-2018-00231
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 12/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/17/2020
Device Model NumberH7493912412370
Device Catalogue Number39124-1237
Device Lot Number21275135
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/18/2017
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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