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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 H7493808012300
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Age at time of event: 18 years or older. (b)(4). Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter. The balloon was loosely folded. There was contrast in the inflation lumen. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 78 cm from the hub. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. There was no evidence of any material or manufacturing deficiencies contributing to the damage. 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
Reportable based on analysis completed on 30-sep-2016. It was reported that shaft kink occurred. The 78% stenosed, 11mm x 3. 0mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery. A 3. 0mmx12mm quantum maverick balloon catheter was advanced for dilation. However, during the delivery of the device, it was noticed that the shaft was kinked. The device was successfully removed from the patient. 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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6059965
MDR Text Key58539413
Report Number2134265-2016-09437
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 09/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model NumberH7493808012300
Device Catalogue Number38080-1230
Device Lot Number19366573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2016
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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