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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL
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BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL Back to Search Results
Model Number M00510880
Device Problems Break (1069); Device-Device Incompatibility (2919); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/21/2019
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 mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2019.The indication for the procedure was a biliary stricture with cholelithiasis.According to the complainant, during the procedure, after several stone extractions with the trapezoid basket.One of the basket wires broke at the distal tip of the basket.Additionally, the side car (guidewire channel) was noted to be broken.The procedure was completed with a balloon.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h2: additional information: blocks b5, d10, h3 and h10 has been updated based on additional information received.Block h6: problem code 1069 captures the reportable event of basket wire break.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.Block h11: correction: g1 (mfr contact first name).
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2019.The indication for the procedure was a biliary stricture with cholelithiasis.According to the complainant, during the procedure, after several stone extractions with the trapezoid basket.One of the basket wires broke at the distal tip of the basket.Additionally, the side car (guidewire channel) was noted to be broken.The procedure was completed with a balloon.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on (b)(6) 2019**** it was reported that the distap tip of the device was cut from the device when the physician had to cut the end of the wire since it tangled with the guidewire,.
 
Manufacturer Narrative
Block h2: additional information: blocks b5, d10, h3 and h10 has been updated based on additional information received.Block h6: problem code 1069 captures the reportable event of basket wire break.Block h10: visual inspection of the returned device found that the side car-rx was torn at the distal section of the device.The tip was detached from the basket assembly which was not returned along with the complaint device.One of the basket wires was cut, the cut section was inspected under magnification and it was noted to be a clean cut which is likely made with a sharp tool.Based on all available information, the investigation concluded that procedural and anatomical factors encountered during the procedure likely affected the device's performance and integrity.Also, handling and manipulation of the device during the procedure and interaction with additional devices could have entangled the guidewire with basket assembly.Additionally, excessive force applied to the handle can lead to tip detachment.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Block h11: correction: g1 (mfr contact first name).
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2019.The indication for the procedure was a biliary stricture with cholelithiasis.According to the complainant, during the procedure, after several stone extractions with the trapezoid basket.One of the basket wires broke at the distal tip of the basket.Additionally, the side car (guidewire channel) was noted to be broken.The procedure was completed with a balloon.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on (b)(6) 2019**** it was reported that the distap tip of the device was cut from the device when the physician had to cut the end of the wire since it tangled with the guidewire,.
 
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Brand Name
TRAPEZOID RX
Type of Device
LITHOTRIPTOR, BILIARY MECHANICAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9331622
MDR Text Key189708438
Report Number3005099803-2019-05596
Device Sequence Number1
Product Code LQC
UDI-Device Identifier08714729296393
UDI-Public08714729296393
Combination Product (y/n)N
PMA/PMN Number
K040447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/04/2020
Device Model NumberM00510880
Device Catalogue Number1088
Device Lot Number0023139221
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2019
Initial Date Manufacturer Received 10/21/2019
Initial Date FDA Received11/15/2019
Supplement Dates Manufacturer Received12/27/2019
01/28/2020
Supplement Dates FDA Received01/22/2020
02/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age75 YR
Patient Weight68
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