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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE REBEL; STENT, CORONARY
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BOSTON SCIENTIFIC - MAPLE GROVE REBEL; STENT, CORONARY Back to Search Results
Model Number H7493927420300
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon leak occurred.The target lesion was located in a coronary artery.After pre-dilatation was performed, a 20 x 3.00 rebel stent was advanced to treat the lesion.However, after the device was positioned in the right location, negative pressure was applied and backflow of blood was noted in the inflation device from the inflation port.The device was completely removed from the patient's body and the procedure was completed with another 20 x 3.00 rebel stent.No patient complications were reported and the patient's status was fine.According to the physician, the actual balloon looked like it was already broken inside the system.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by mfr: returned product consisted of a rebel stent delivery system (sds) with stent.The stent, balloon, shaft, tip and markerbands were microscopically examined.There was blood in the hub, and inflation lumen.The balloon was tightly folded with the stent secure between the markerbands.There were numerous kinks throughout the hypotube.The proximal end of the stent was damaged with a strut bent/flared.The end of the core wire was protruding out of the outer shaft.Engineering lightly stretched the outer shaft causing the core wire to recess back within the outer shaft.Functional testing was performed by attaching an inflation device filled with water to the device.When positive pressure was applied, a stream of water emitted from the hole in the shaft causing the device not to inflate.Inspection of the remainder of the device revealed no other damage or irregularities.No other issues were identified during the product analysis.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 balloon leak occurred.The target lesion was located in a coronary artery.After pre-dilatation was performed, a 20 x 3.00 rebel stent was advanced to treat the lesion.However, after the device was positioned in the right location, negative pressure was applied and backflow of blood was noted in the inflation device from the inflation port.The device was completely removed from the patient's body and the procedure was completed with another 20 x 3.00 rebel stent.No patient complications were reported and the patient's status was fine.According to the physician, the actual balloon looked like it was already broken inside the system.
 
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Brand Name
REBEL
Type of Device
STENT, CORONARY
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 Key6453002
MDR Text Key71489053
Report Number2134265-2017-02344
Device Sequence Number1
Product Code MAF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SIMILAR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2019
Device Model NumberH7493927420300
Device Catalogue Number39274-2030
Device Lot Number18829088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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