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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 H7493808015270
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2016
Event Type  malfunction  
Manufacturer Narrative
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 tightly 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 70.5 cm from the tip.The fracture faces were oval as if kinked prior to separation.There was tip damage.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 device analysis completed on 08-dec-2016.It was reported that shaft kink occurred.The 90% stenosed target lesion was located in the coronary artery.A 2.75mm x 15mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion but the balloon shaft was kinked.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 Name
QUANTUM¿ MAVERICK¿
Type of Device
CATHETERS, 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 Key6182598
MDR Text Key62682683
Report Number2134265-2016-11917
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392774
UDI-Public(01)08714729392774(17)20181130(10)18635720
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 Physician
Type of Report Initial
Report Date 12/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Model NumberH7493808015270
Device Catalogue Number38080-1527
Device Lot Number18635720
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2016
Initial Date FDA Received12/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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