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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX?; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX?; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number H7493912415400
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/25/2014
Event Type  malfunction  
Event Description
It was reported that balloon pinhole occurred.The 70% stenosed, 16x4mm, concentric target lesion contained >45 and <90 degree bend and was located in the non-tortuous and a non-calcified right coronary artery (rca).Following the insertion of a 6fr non-bsc guide catheter, a 3.5x38mm non-bsc stent was advanced and deployed to the target lesion.Subsequently, a 15mm x 4.00mm nc quantum apex¿ balloon catheter was selected for use and advanced for "post expansion" to improve stent expansion.However, when fluoroscopy was performed, filtration of the contrast was seen when the balloon was inflated.The physician reviewed the device and noted that the balloon has hole where the contrast escapes.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon pinhole occurred.The 70% stenosed, 16x4mm, concentric target lesion contained >45 and <90 degree bend and was located in the non-tortuous and a non-calcified right coronary artery (rca).Following the insertion of a 6fr non-bsc guide catheter, a 3.5x38mm non-bsc stent was advanced and deployed to the target lesion.Subsequently, a 15mm x 4.00mm nc quantum apex¿ balloon catheter was selected for use and advanced for "post expansion" to improve stent expansion.However, when fluoroscopy was performed, filtration of the contrast was seen when the balloon was inflated.The physician reviewed the device and noted that the balloon has hole where the contrast escapes.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a nc quantum apex balloon catheter.The device was pressurized with an inflation device filled with water.A pinhole was identified in the shaft material at the proximal edge of the proximal balloon bond.There were scratches on the proximal balloon weld which extended to the balloon.Microscopic examination of the balloon presented no irregularities in the balloon material, shaft material or the ro marker that could have contributed to the damage.Inspection of the remainder of the device, apart from the observed damage, revealed 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).
 
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Brand Name
NC QUANTUM APEX?
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4106888
MDR Text Key4762536
Report Number2134265-2014-05759
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K121667
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/02/2016
Device Model NumberH7493912415400
Device Catalogue Number39124-1540
Device Lot Number16071109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/06/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
3.5X38MM RESOLUTE STENT; JL 6FR GUIDE CATHETER
Patient Age68 YR
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