MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510880

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, when putting pressure on the basket the wire frayed and left the basket open inside the patient.With the stone still inside the basket, the physician shook the basket until the stone was released.The basket was pulled out and another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.An alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, when putting pressure on the basket the wire frayed and left the basket open inside the patient.With the stone still inside the basket, the physician shook the basket until the stone was released.The basket was pulled out and another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.The size of the stone was approximately 1cm.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code a0401 captures the reportable event of pull wire break.Block h10: the device has been received for analysis.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.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code a0401 captures the reportable event of pull wire break.Block h10: visual analysis of the returned device found the pull wire was not broken, not confirming the reported event.However, the handle cannula was found pulled out of the finger ring portion of the handle assembly and lodged inside the working length.The working length was cut to expose and inspect the handle cannula.Both dimples from the screws were found visible at proximal section of the handle cannula.Drag marks were present from dimples towards the proximal end as the cannula had been forcibly pulled out from the set screws.The distal screw and proximal screw depth were measured and found within specification.The handle cannula, pull wire and working length were found kinked/bent.The sheath was found torn at the proximal section and the coil assembly was found deformed (unraveled/stretched).Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device's performance and integrity.Handling and manipulation of the device during its use can result in kinks/bends in the device.This condition would cause friction between the components at kinked/bent areas causing difficulty to open or close the basket.Continued attempts to open or close the basket can result in handle cannula detachment from finger ring.Drag marks observed in the handle cannula indicated that force was applied to the handle which could have contributed with the handle cannula detachment.It is likely that the basket was pulled causing the handle cannula to bend and lodge in the working length.It also stretched the coil assembly, suggesting excessive manipulation of the device during the procedure.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.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.An alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, when putting pressure on the basket the wire frayed and left the basket open inside the patient.With the stone still inside the basket, the physician shook the basket until the stone was released.The basket was pulled out and another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Additional information received on (b)(6) 2021.The size of the stone was approximately 1cm.

• 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 Key: 11211257
• MDR Text Key: 228171516
• Report Number: 3005099803-2021-00200
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2021

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 Date: 11/13/2020
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0024769461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 01/27/2021; 02/18/2021
• Supplement Dates FDA Received: 02/18/2021; 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1