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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 H7493808015400
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 12/21/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr. : returned product consisted of a quantum maverick balloon catheter. The balloon was loosely folded. The shaft is intact; there is no shaft separation. The outer shaft, inner shaft, balloon and tip were microscopically examined. The tip is damaged. There are numerous hypotube and shaft kinks. Inspection of the remainder of the device revealed no other damage or irregularities. 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. Bsc id: (b)(4), tw: (b)(4).
 
Event Description
It was reported that shaft break occurred. The 85% stenosed, 15x4. 00mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery. During unpacking of a 4. 0mm x 15mm quantum¿ maverick¿ balloon catheter, it was noted that the device delivery shaft was fractured. The procedure was completed with another of the same device. No patient complications were reported and patient's status was stable.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that shaft break occurred. The 85% stenosed, 15x4. 00mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery. During unpacking of a 4. 0mm x 15mm quantum¿ maverick¿ balloon catheter, it was noted that the device delivery shaft was fractured. The procedure was completed with another of the same device. No patient complications were reported and 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 Key7204334
MDR Text Key280132287
Report Number2134265-2018-00039
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08714729392828
UDI-Public08714729392828
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 12/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/17/2020
Device Model NumberH7493808015400
Device Catalogue Number38080-1540
Device Lot Number0020663866
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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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