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

Model Number M00510890

Device Problem Break (1069)

Patient Problem Inflammation (1932)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).Reported event of pull wire broken.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 lithotripter basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, an ultratome was used to cut the papilla which was then dilated by a cre balloon.A jagwire guidewire was then passed through reaching the cbd.The trapezoid basket was inserted over the guidewire to capture a 20.1mm x 22.7mm sized stone.The stone was captured, and the trapezoid was used in conjunction with an alliance handle to crush the stone.However when the handle was actuated, the pull wire broke leaving the stone trapped inside the basket.The physician then attempted to detach the tip of the basket using a non-bsc forceps, but failed.A second physician then assisted with the case and used a sohendra lithotripsy to assist with removal of the stone.When the physician attempted to crush the stone with the sohendra lithotripsy device, the pull wire broke again leaving the basket with entrapped stone inside patient.The physician opted to place a non-bsc double pigtail plastic stent to facilitate biliary drainage.An embd (plastic tube) was used to cover the pull wire to prevent bile duct injury.The basket with the entrapped stone was left inside the patient and an electrohydraulic lithotripsy (ehl) was scheduled on (b)(6) 2016.On (b)(6) 2016, the stone was successfully removed using a spyglass ds and laser.Reportedly, patient was on antibiotic therapy for the treatment of cholangitis that developed post procedure.Patient was discharged on (b)(6) 2016 and was scheduled for an outpatient follow-up.

Manufacturer Narrative

Visual examination of the returned device found that the basket/wire assembly was pulled out of the coil assembly.The basket wires were found to be bent and unevenly spaced, and the tip was intact.The handle cannula was bent upward inside the handle body.The side car-rx presented pushback out of specification.The pull wire was found to have failed and broken from the distal the end of handle cannula.Both ends of the fractured pull wire were necked down and broken into "v" shape indicating that the wire had most likely sheared apart.Evaluation concluded that the condition of the returned unit was consistent with the complaint that the pull wire was broken.Although it cannot be determined precisely how the pull wire failed, stone size and density, user technique, tortuous anatomy and other procedural factors could possibly contribute to the failure by causing the tensile force applied by the user to not be fully distributed throughout the device.Therefore, the most probable root cause of this complaint is "operational context." the device history record (dhr) review found that the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed and there is not enough information to determine 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 basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, an ultratome was used to cut the papilla which was then dilated by a cre balloon.A jagwire guidewire was then passed through reaching the cbd.The trapezoid basket was inserted over the guidewire to capture a 20.1mm x 22.7mm sized stone.The stone was captured, and the trapezoid was used in conjunction with an alliance handle to crush the stone.However when the handle was actuated, the pull wire broke leaving the stone trapped inside the basket.The physician then attempted to detach the tip of the basket using a non-bsc forceps, but failed.A second physician then assisted with the case and used a sohendra lithotripsy to assist with removal of the stone.When the physician attempted to crush the stone with the sohendra lithotripsy device, the pull wire broke again leaving the basket with entrapped stone inside patient.The physician opted to place a non-bsc double pigtail plastic stent to facilitate biliary drainage.An embd (plastic tube) was used to cover the pull wire to prevent bile duct injury.The basket with the entrapped stone was left inside the patient and an electrohydraulic lithotripsy (ehl) was scheduled on (b)(6) 2016.On (b)(6) 2016, the stone was successfully removed using a spyglass ds and laser.Reportedly, patient was on antibiotic therapy for the treatment of cholangitis that developed post procedure.Patient was discharged on (b)(6) 2016 and was scheduled for an outpatient follow-up.

• 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: 5626580
• MDR Text Key: 44286508
• Report Number: 3005099803-2016-01104
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

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: Physician
• Device Expiration Date: 01/31/2017
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 18871889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR