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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 H7493808008250
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/22/2016
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. 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 69 cm from the tip. The fracture faces were oval as if kinked prior to separation. There were numerous hypotube kinks. There was no evidence of any material or manufacturing deficiencies contributing to the damage. 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 28-oct-2016. It was reported that shaft kink occurred. The target lesion was located in the coronary artery. A 2. 5mm x 8mm quantum¿ maverick¿ balloon catheter was advanced to dilate the lesion. However, it was noted that the shaft was kinked. The procedure was completed with a different device. No patient complications were reported. However, returned device analysis revealed hypotube break.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the device may have been fractured upon removal. It was simply removed the device from the patient's body. 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 Key6113499
MDR Text Key60437922
Report Number2134265-2016-10377
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 10/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model NumberH7493808008250
Device Catalogue Number38080-0825
Device Lot Number18994148
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/04/2016
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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