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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 Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter. The tip was damaged. The hypotube and shaft were examined. The hypotube shaft was completely separated 87. 5cm 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. There were numerous hypotube kinks. There was no evidence of any material or manufacturing deficiencies contributing to the damage. The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact. (b)(4).
 
Event Description
It was reported that shaft break occurred. During preparation of a 3. 0mm x 12mm quantum maverick balloon catheter, it was noted that the delivery shaft was fractured. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that shaft break occurred. During preparation of a 3. 0mm x 12mm quantum¿ maverick¿ balloon catheter, it was noted that the delivery shaft was fractured. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.
 
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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 Key7208726
MDR Text Key270789478
Report Number2134265-2018-00140
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392675
UDI-Public08714729392675
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,Followup
Report Date 01/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2020
Device Model NumberH7493808012300
Device Catalogue Number38080-1230
Device Lot Number0020890302
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2017
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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