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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 H7493808012250
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/21/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4). Returned product consisted of a quantum maverick balloon catheter. The balloon was tightly folded. There was contrast in the inflation lumen. There was blood in between balloon folds. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 52. 5 cm from the tip. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. There as tip damage. There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty. 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 april 18, 2017. It was reported that shaft damaged occurred. The target lesion was located in the coronary artery. A 2. 5mm x 12mm quantum¿ maverick¿ balloon catheter was advanced for dilatation. However, it was noticed the shaft was damaged. No patient complications were reported. 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 Key6525719
MDR Text Key73824230
Report Number2134265-2017-04379
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeIN
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 04/18/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2018
Device Model NumberH7493808012250
Device Catalogue Number38080-1225
Device Lot Number17764573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2015
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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