MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRAPEZOID? RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510890

Device Problem Material Deformation (2976)

Patient Problem Inflammation (1932)

Event Date 02/02/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter compatable basket was used in the common bile duct during a lithotripsy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, when the trapezoid¿ rx basket was inserted into the common bile duct via the guidewire, the side car-rx appeared to be pushed back at 5mm.Reportedly, the basket tip deviated into the pancreatic duct and the patient developed pancreatitis due to the contrast medium that would go into the pancreas.Another trapezoid¿ rx basket was used to complete the procedure.Additionally, it is unknown if the patient had history of pancreatitis prior to the procedure.The patient's amylase level increased but is continuously monitored post procedure.No any other interventions were provided.The patient's most current condition was reported to be "good.".

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Reported event of side car - rx pushback.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 medwatch will be filed.

Manufacturer Narrative

A visual examination of the returned device found the basket to be fully retracted and the side car-rx presented pushback out of specification.Additionally, the side car-rx was torn.A functional evaluation was performed and the basket wires were found to be properly formed and evenly spaced.The evaluation concluded that the condition of the returned unit was consistent with the complaint incident that the device presented side car-rx to be pushed back.The side car-rx pushback and tear could cause difficulty in tracking the device over the guidewire through the papilla and into the common bile duct.The side car-rx pushback most likely occurred as the device was placed into the working channel of the scope or as the device was advanced past the scope elevator and into the papilla.Therefore, the most probable root cause classification for the reported failure is ¿operational context¿.A labeling review was performed and there is no evidence that the device was not used in accordance with the labeling.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter compatable basket was used in the common bile duct during a lithotripsy procedure performed on (b)(6) 2015.According to the complainant, during the procedure, when the trapezoid⠒x basket was inserted into the common bile duct via the guidewire, the side car-rx appeared to be pushed back at 5mm.Reportedly, the basket tip deviated into the pancreatic duct and the patient developed pancreatitis due to the contrast medium that would go into the pancreas.Another trapezoid⠒x basket was used to complete the procedure.Additionally, it is unknown if the patient had history of pancreatitis prior to the procedure.The patient's amylase level increased but is continuously monitored post procedure.No any other interventions were provided.The patient's most current condition was reported to be "good".

• Brand Name: TRAPEZOID? RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4561436
• MDR Text Key: 5559291
• Report Number: 3005099803-2015-00437
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2015

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: M00510890
• Device Catalogue Number: 1089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2015
• Initial Date FDA Received: 03/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other