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

Model Number M00510870

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problems Pneumonia (2011); Thrombosis (2100); No Code Available (3191)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2019 as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplement mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used during an endoscopic retrograde cholangiopancreaticography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, an attempt to crush a stone using the trapezoid basket was performed; however the stone would not break and was stuck inside the basket.The handle was then cut, and a soehendra lithotripsy system was attached to attempt to crush the stone.However, the catheter snapped in half just outside the patient's mouth.The length of the catheter was not enough to reattach the soehendra.The patient was then taken to surgery to remove the stuck basket and stone.

Manufacturer Narrative

G2: medwatch number mw5084479.H2: additional information - b3, b5, e4, g3, and h6.D4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.H6: patient code 3191 captures the reportable event of surgery.Device code 2907 captures the reportable event of pull wire detached.Device code 1670 captures the reportable event of failure to crush stone.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned".H10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplement mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used during an endoscopic retrograde "cholangiopancreatography" (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, an attempt to crush a stone using the trapezoid basket was performed; however the stone would not break and was stuck inside the basket.The handle was then cut, and a soehendra lithotripsy system was attached to attempt to crush the stone.However, the catheter snapped in half just outside the patient's mouth.The length of the catheter was not enough to reattach the soehendra.The patient was then taken to surgery to remove the stuck basket and stone.Additional information received as of april 30, 2019.Ercp procedure was performed on (b)(6) 2018.Patient with post-operative complications of thrombus, pneumonia, and drains.

• 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: 8401422
• MDR Text Key: 138156524
• Report Number: 3005099803-2019-01064
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

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 Model Number: M00510870
• Device Catalogue Number: 1087
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention