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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY NEPHROMAX¿; CATHETER, NEPHROSTOMY
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BOSTON SCIENTIFIC - GALWAY NEPHROMAX¿; CATHETER, NEPHROSTOMY Back to Search Results
Model Number M0062101420
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/08/2016
Event Type  Injury  
Event Description
It was reported to boston scientific corporation that a nephromax was used for right percutaneous nephrolithotomy performed on (b)(6) 2016.According to the complainant, during procedure, the surgeon inserted the balloon and found out that there was an ro marker detached inside the patient floating along the amplatz super stiff wire.The ro marker was visible through the nephroscope.After the stone was removed, the patient was under anesthesia for one more hour longer than necessary to retrieve the ro marker using graspers.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Visual examination of the returned nephromax revealed that the balloon was partially inflated with liquid.The marker band was clearly present on the shaft inside the balloon.One tantalum marker was found attached to the shaft inside the balloon and was positioned to align with the distal end of the dilatation zone of the balloon.The detached ro marker band was also found slightly flattened.The width of the marker band was measured using calibrated calipers, the marker band measured 1.18mm; however, it was noted that the minimum width for the ro marker band used on this device was 1.51mm.Therefore, the marker band that was returned did not originate from the bsc device and the exact origin of this marker band was unknown.Based on all gathered information, the most probable root cause classification is caused by other.Udi= (b)(4).
 
Event Description
It was reported to boston scientific corporation that a nephromax was used for right percutaneous nephrolithotomy performed on (b)(6) 2016.According to the complainant, during procedure, the surgeon inserted the balloon and found out that there was an ro marker detached inside the patient floating along the amplatz super stiff wire.The ro marker was visible through the nephroscope.After the stone was removed, the patient was under anesthesia for one more hour longer than necessary to retrieve the ro marker using graspers.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand Name
NEPHROMAX¿
Type of Device
CATHETER, NEPHROSTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key5619148
MDR Text Key43982561
Report Number3005099803-2016-01123
Device Sequence Number1
Product Code LJE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952968
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 04/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/27/2019
Device Model NumberM0062101420
Device Catalogue Number210-142
Device Lot Number0018857096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age44 YR
Patient Weight91
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