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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 10/27/2016
Event Type  malfunction  
Manufacturer Narrative
(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. Device analysis determined the condition of the returned device was consistent with the complaint incident. The outer shaft, inner shaft, balloon and tip were microscopically examined. The hypotube shaft was completely separated 64 cm from the hub. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. Inspection of the remainder of the device presented no other damage or irregularities. 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 18-nov-2016. It was reported that shaft kinked occurred. The target lesion was located in the coronary artery. A 3. 00mm x 12mm quantum¿ maverick¿ balloon catheter was advanced however, it was noted that the shaft kinked during delivery. The procedure was completed with another of the same device. No complications were reported and 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
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6144062
MDR Text Key61402717
Report Number2134265-2016-11107
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 11/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model NumberH7493808012300
Device Catalogue Number38080-1230
Device Lot Number19487850
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2016
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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