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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IRRIGATION; CATHETER, UROLOGICAL
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BOSTON SCIENTIFIC CORPORATION IRRIGATION; CATHETER, UROLOGICAL Back to Search Results
Model Number M0067201010
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as no event date was reported.  (b)(4).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.
 
Event Description
It was reported to boston scientific corporation that a single action pumping system (saps) was unpacked on an unknown date.According to the complainant, while unpacking, a hair like object was found inside the packaging.The procedure was completed with another saps device.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Date of event was approximated to (b)(6) 2018 as no event date was reported.  (b)(4).A visual examination of the returned complaint device did not show visual defects, the device was closed/sealed and packaged inside its original pouch.The sealed section of the returned pouch looks good and without damages; however, a small hair was found to be inside the pouch.No other issue was noted.Based on the condition and evaluation of the returned device, the most probable root cause is manufacturing deficiency since the issue was traced to the manufacturing process.An investigation to address this issue has been completed.
 
Event Description
It was reported to boston scientific corporation that a single action pumping system (saps) was unpacked on an unknown date.According to the complainant, while unpacking, a hair like object was found inside the packaging.The procedure was completed with another saps device.There were no patient complications reported as a result of this event.
 
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Brand Name
IRRIGATION
Type of Device
CATHETER, UROLOGICAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8064105
MDR Text Key127210833
Report Number3005099803-2018-61336
Device Sequence Number1
Product Code KQT
UDI-Device Identifier08714729752998
UDI-Public08714729752998
Combination Product (y/n)N
PMA/PMN Number
K870557
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/17/2022
Device Model NumberM0067201010
Device Catalogue Number720-101S
Device Lot Number0022266713
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/30/2018
Date Manufacturer Received11/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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