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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 H7493912415250
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 05/05/2017
Event Type  malfunction  
Manufacturer Narrative
Corrected device lot number from 18577043 to 18571978. Corrected device manufactured date from 11/02/2015 to 10/30/2015. Device evaluated by mfr: returned product consisted of the nc quantum apex balloon catheter. The balloon, tip, shaft, and hypotube were microscopically and tactile inspected. There was contrast in the inflation lumen and blood in the guidewire lumen. The balloon was tightly folded. Microscopic examination and tactile inspection revealed numerous kinks throughout the hypotube and a complete hypotube separation 71. 5cm from the end of the strain relief. The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation. Inspection of the remainder of the device, apart from the observed damage, 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 further reported that the target lesion was located in the left circumflex artery (lcx). During advancing, the shaft was fractured more than 15cm from the hub and the device was removed together with the guide catheter.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that shaft break occurred. A 15mm x 2. 50mm nc quantum apex¿ balloon catheter was selected for use to dilate the lesion. However, during preparation, it was noted that the shaft was fractured. The device was not used and the procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.
 
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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 Key6631212
MDR Text Key164914382
Report Number2134265-2017-05745
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2018
Device Model NumberH7493912415250
Device Catalogue Number39124-1525
Device Lot Number18571978
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2015
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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