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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 H7493808015300
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4).
 
Event Description
It was reported that shaft break occurred. A 3. 0mm x 15mm quantum¿ maverick¿ balloon catheter was advanced for dilatation. However upon advancing, the shaft broke. The procedure was completed with another of the same device. No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of the proximal portion of the quantum maverick balloon. Portion of the hypotube, the distal shaft, the balloon, the markerbands, and the tip were not returned for product analysis. The shaft, hypotube, and bonds were microscopically and visually examined. There was also, a complete hypotube separation 79. 5cm from the strain relief. The hypotube fracture surface was ovaled, which suggests the device was kinked prior to separation. The shaft and bonds could not be analyzed as there were not returned for analysis. Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities. No other issues were identified during the product analysis. Device analysis determined the condition of the returned device was consistent with the reported information. 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
It was reported that shaft break occurred. A 3. 0mm x 15mm quantum¿ maverick¿ balloon catheter was advanced for dilatation. However upon advancing, the shaft broke. 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 Key6200214
MDR Text Key63209900
Report Number2134265-2016-12064
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,Followup
Report Date 12/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model NumberH7493808015300
Device Catalogue Number38080-1530
Device Lot Number19427834
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2016
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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