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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX NEEDLE KNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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BOSTON SCIENTIFIC CORPORATION RX NEEDLE KNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number M00545840
Device Problems Material Deformation (2976); Appropriate Term/Code Not Available (3191)
Patient Problems Swelling (2091); Swelling/ Edema (4577)
Event Date 11/27/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a rx needle knife xl was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the needle knife was advanced into the duodenoscope and the needle was extended, it was noticed that the needle was bent.The device was removed from the duodenoscope and attempts to straighten the needle were not successful.Reportedly, there was no damage to the device out of the package.Additionally, there was swelling noted in the anatomy after the device was removed as a result of "trying to get in up until that point".The procedure was rescheduled to allow the swelling to subside.The procedure was successfully completed a couple days later using a jagtome revolution device.
 
Manufacturer Narrative
Block h6 (device codes): medical device problem code a27 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned rx needle knife xl was analyzed, and a visual evaluation noted that the cutting wire was bent.A dimensional and functional evaluation noted that the cutting wire extension length and handle actuation were within specifications.No other issues with the device were noted.The reported swelling is a known inherent risk of the device and is listed as a potential risk of the device in the device's instructions for use.The reported event was confirmed.Upon analysis, it was found that cutting wire was bent.Based on the condition of the device, the problem found could be caused by manipulation of the device during the procedure, or if the cutting wire was not fully retracted when advancing into the endoscope.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
 
Event Description
It was reported to boston scientific corporation that a rx needle knife xl was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, when the needle knife was advanced into the duodenoscope and the needle was extended, it was noticed that the needle was bent.The device was removed from the duodenoscope and attempts to straighten the needle were not successful.Reportedly, there was no damage to the device out of the package.Additionally, there was swelling noted in the anatomy after the device was removed as a result of "trying to get in up until that point".The procedure was rescheduled to allow the swelling to subside.The procedure was successfully completed a couple days later using a jagtome revolution device.
 
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Brand Name
RX NEEDLE KNIFE XL
Type of Device
UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key11056775
MDR Text Key223183576
Report Number3005099803-2020-06360
Device Sequence Number1
Product Code KNS
UDI-Device Identifier08714729283799
UDI-Public08714729283799
Combination Product (y/n)N
PMA/PMN Number
K973826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/22/2022
Device Model NumberM00545840
Device Catalogue Number4584
Device Lot Number0026058229
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2020
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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