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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 H7493808015350
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/06/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Returned product consisted of a quantum maverick balloon catheter in two pieces. The balloon was loosely folded. There was dried contrast in the balloon and inflation lumen. The hub, hyptotube, port/exit notch, inner/outer shaft, balloon and tip of the device were microscopically and tactile inspected. Inspection revealed the hypotube was separated 59cm from the strain relief, numerous kinks in the hypotube, and kinks in the distal shaft located 96mm and 99mm from the tip of the device. The separated ends of the hypotube were ovalized, as if the hypotube was kinked prior to separation. Inspection of the remainder of the device presented no other damage or irregularities. 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
Reportable based on device analysis completed on (b)(6) 2017. It was reported that shaft kink occurred. The target lesion was located in the coronary artery. A 3. 5mm x15mm quantum maverick balloon catheter was selected but it was noted that the shaft was kinked. The procedure was completed with another with the same device. No patient complications were reported and patient status was stable. However, returned device analysis revealed hypotube break.
 
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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 (Section G)
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 Key7051135
MDR Text Key93080047
Report Number2134265-2017-11371
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
P860019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 11/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model NumberH7493808015350
Device Catalogue Number38080-1535
Device Lot Number20419953
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/02/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2017
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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