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

Model Number M00510890

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

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 been received for analysis; however, the analysis has not yet been completed.Upon 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 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 to crush a 2cm stone.During the attempt, the thumb ring broke off of the handle causing the basket to be stuck inside the patient; however, the physician managed to remove the stone from the basket and the basket was pulled out of the patient without additional intervention.The procedure was not completed and the patient was rescheduled for a lithotripsy with spyglass procedure to remove the stone.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

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 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Device code 1069 captures the reportable event of thumb ring break.Block h10: visual inspection of the returned device found that the working length was free of obvious kinks and bends.The tip was still attached to the basket-wire assembly.The thumb ring was detached from the handle.Therefore, the reported complaint is confirmed.The handle and thumb ring showed coincident marks that indicate proper assembly during manufacturing process.The handle had marks where the thumb ring was located indicating likely a lot of force was applied to the device.Functional inspection found the basket will extend and retract without any issues.Based on all available information, it is most likely that procedural or anatomical factors encountered during procedure could have affected the device's performance and integrity.Probably, during use of the device, the thumb ring received tensile and/or compressive force(s) applied parallel to the length of the device.Detachment of the thumb ring from the handle assembly can occur when force is applied perpendicular to the thumb ring/handle assembly, forcing the thumb ring out of the handle assembly.Damages observed in the section of the handle where the thumb ring was located indicates that the device was submitted to tension forces during the use of the device.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.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket to crush a 2cm stone.During the attempt, the thumb ring broke off of the handle causing the basket to be stuck inside the patient; however, the physician managed to remove the stone from the basket and the basket was pulled out of the patient without additional intervention.The procedure was not completed and the patient was rescheduled for a lithotripsy with spyglass procedure to remove the stone.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 10583780
• MDR Text Key: 208546581
• Report Number: 3005099803-2020-04088
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• 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
• Report Date: 10/26/2020

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 Date: 06/29/2021
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0025652655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1