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

Model Number M00510880

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 03/13/2019

Event Type  Injury  

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 device was used for an endoscopic retrograde cholangiopancreatography (ercp) procedure with calculi extraction performed in the common bile duct on (b)(6) 2019.According to the complainant, during the procedure, the basket caught the 10-12mm stone.The stone was attempted to be crushed using an alliance handle; however, the stone was unable to be crushed.The tip of the basket would not deploy, therefore trapping the stone inside the basket.The procedure was concluded at this time, and on (b)(6) 2019, the patient underwent biliary tract exploration for extraction of the basket.The patient's condition at the conclusion of the procedures was reported to be stable.

Event Description

It was reported to boston scientific corporation that a trapezoid rx device was used for an endoscopic retrograde cholangiopancreatography (ercp) procedure with calculi extraction performed in the common bile duct on (b)(6) 2019.According to the complainant, during the procedure, the basket caught the 10-12mm stone.The stone was attempted to be crushed using an alliance handle; however, the stone was unable to be crushed.The tip of the basket would not deploy, therefore trapping the stone inside the basket.The procedure was concluded at this time, and on (b)(6) 2019, the patient underwent biliary tract exploration for extraction of the basket.The patient's condition at the conclusion of the procedures was reported to be stable.

Manufacturer Narrative

Block h6: patient code 3191 captures the reportable event of surgery.Device code 2547 captures the reportable event of tip failure to separate.Block h10: visual analysis found the returned device divided in two different parts.The working length (including the coil and sheath) was found cut at its proximal end (distal end of the heat shrink).The cut section of the unit showed drag marks, indicating the use of an unknown tool to perform the cut.Moreover, the coil was found to be kinked in several locations and stretched.Residues were present in the device indicating use and handling.Additionally, it was noted that the pull wire (including the basket) was pulled out from the internal section of the coil assembly, and the pull wire/basket were not returned for inspection; hence product analysis could not be performed for this part of the unit and specifically to the tip, which is the defective part reported by the user; consequently, not confirming the reported complaint.The calculi in the complaint was reported to be 10--12 mm.Per the dfu, the trapezoid rx wireguided retrieval basket 3 cm basket is designed for crushing calculus larger than 1.5 cm (15 mm)) in diameter."with the device being used to crush a calculus outside of the size the product was designed for, the unit could not be effective during its use.It is highly possible that the product was removed from the patient in an incorrect way, as the tip of the basket would be unable to detach properly since the stone was smaller than the basket is designed for, and the force needed to detach the tip would not be enough.Based on all the gathered information and the inspection performed, it was determined that the issue reported by the user (tip failure to separate), could have been generated due to the incorrect use of the device by the user.Therefore, the most probable root cause is unintended use error caused or contributed to event since it is most likely that the interaction between the user and device or sample, including unintended inappropriate use of the device and incorrect sample preparation, caused or contributed to the error.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 8492442
• MDR Text Key: 141228939
• Report Number: 3005099803-2019-01691
• 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
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0022806993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 05/03/2019
• Supplement Dates FDA Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 70