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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 Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Returned product consisted of a quantum maverick balloon catheter in two pieces. The balloon was loosely folded with blood in the inflation lumen and balloon. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated from the hub. The fracture faces were oval as if kinked prior to separation. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The investigation conclusion is operational context as the product meets the design and 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 07-dec-2017. It was reported that shaft kink occurred. The 75% stenosed, 15x3. 5mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery. A 3. 5mm x 15mm quantum¿ balloon catheter was selected to dilate the lesion. However, the shaft was kinked 70 cm from the hub. The procedure was completed with another of the same device. No patient complications were reported and the patient's 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 Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7140962
MDR Text Key95665916
Report Number2134265-2017-12595
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392804
UDI-Public08714729392804
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 12/07/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model NumberH7493808015350
Device Catalogue Number38080-1535
Device Lot Number20486021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/05/2017
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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