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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROSTOMY CATHETER SETS; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
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BOSTON SCIENTIFIC CORPORATION NEPHROSTOMY CATHETER SETS; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY Back to Search Results
Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)
Patient Problems Bacterial Infection (1735); Hemorrhage/Bleeding (1888)
Event Date 11/24/2019
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.(b)(6).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a nephrostomy catheter set was used in the kidney during a nephrostomy procedure.According to the complainant, the patient already had a nephrostomy tube for almost 20 years.Reportedly, the patient just had her tube changed; however, it was noticed that there was blood clotting into two of the holes as she was bleeding at her back.It was noted that the main opening at the end of the catheter was clear but it was leaking at the other back at the port.The patient was having a frequent leakage for the last 6 to 7 weeks.Patient used to have a catheter change every 90 days when it was first started but bumped it up to 60 days within the last year multicare up in washington state and other hospitals that they got multicare.It was also noted that the catheter was changed from one brand of catheter to boston scientific catheter and that leakage would still happen.Just a couple days in the hospital, they gave her iv of antibiotics just trying to get the infection corrected and get the bag cleared up.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that a nephrostomy catheter set was used in the kidney during a nephrostomy procedure.According to the complainant, the patient already had a nephrostomy tube for almost 20 years.Reportedly, the patient just had her tube changed; however, it was noticed that there was blood clotting into two of the holes as she was bleeding at her back.It was noted that the main opening at the end of the catheter was clear but it was leaking at the other back at the port.The patient was having a frequent leakage for the last 6 to 7 weeks.Patient used to have a catheter change every 90 days when it was first started but bumped it up to 60 days within the last year multicare up in washington state and other hospitals that they got multicare.It was also noted that the catheter was changed from one brand of catheter to boston scientific catheter and that leakage would still happen.Just a couple days in the hospital, they gave her iv of antibiotics just trying to get the infection corrected and get the bag cleared up.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***additional information received on (b)(6) 2019*** on (b)(6) 2019 an appointment for tube change was made.Both boston scientific and an argon drainage catheter were brought out for comparison.It was noted that the holes in the sides of the tube near the bottom are definitely narrower on the boston scientific device than the argon.For the past month, the patient had the boston scientific catheter and there has been no leaking around the incision.Additionally, they feel that the mucus or blood clots due to the uti may have caused the leak.
 
Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: the events were reported to have happened in multiple facilities.Two facilities reported: (b)(6) and (b)(6).Block h10: although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
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Brand Name
NEPHROSTOMY CATHETER SETS
Type of Device
CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9488789
MDR Text Key178739097
Report Number3005099803-2019-06127
Device Sequence Number1
Product Code GBO
Combination Product (y/n)N
PMA/PMN Number
K944290
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Initial Date Manufacturer Received 11/26/2019
Initial Date FDA Received12/18/2019
Supplement Dates Manufacturer Received12/23/2019
Supplement Dates FDA Received01/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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