MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number UNK-P-JAGWIRE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); No Code Available (3191)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Report source: (b)(6) clinical study.(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 an exalt model d single-use duodenoscope was used with a jagwire during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2020 as part of the (b)(6) clinical study.There were no reported malfunctions associated with the exalt scope or jagwire.The patient had a history of an abnormal imaging finding showing a grossly dilated pancreaticobiliary tree on computerized tomography (ct)/magnetic resonance (mr).The patient also had a history of 1 previous ercp, prior biliary sphincterotomy (major papilla), cholecystectomy, previous endoscopic sphincterotomy in 2017, gastroesophageal reflux disease (gerd) with history of barret's, chronic abdominal pain (status post fundoplication x2 for refractory gerd), nausea/vomiting status post extensive outpatient workup, chronic constipation, seizure disorder, migraines, depression, and bipolar disorder.This complaint is being reported based on the event of gastrointestinal (gi) bleeding from nausea/vomiting -mallory weiss tear, and pancreatitis requiring hospitalization.According to the complainant, the mallory weiss tear with gi bleed is not related to the jagwire.According to the complainant, the ercp on (b)(6) 2020 was performed due to abdominal pain related to suspected biliary or pancreatic origin, epigastric abdominal pain, abdominal pain in left and right upper quadrants, biliary dilation on ct scan, and abnormal magnetic resonance cholangiopancreatography (mrcp).During the ercp, normal esophagus and a 360 degree nissen fundoplication was observed.The upper third of main bile duct and middle third of main bile duct were moderately dilated.There was also mild dilation of the ventral pancreatic duct in the head of the pancreas.The biliary tree was swept and sludge was found.One temporary stent was placed into the ventral pancreatic duct.Following the ercp, the patient was reexamined on (b)(6) 2020.The abdomen and pelvis were viewed under ct with intravenous (iv) contrast and showed the following: likely diffuse pancreatitis with peripancreatic fluid extending around right kidney and along right colic gutter all the way to pelvis, interval development of right sided hydronephrosis without definite obstructing lesion, persistent biliary and pancreatic ductal dilation, stable 5 mm cyst in the tail of pancreas, edema of the 2nd portion of the duodenum, likely secondary to pancreatitis, and disc protrusion of likely focal extrusion lateral recess l4-l5 on the left.The patient experienced a drop in baseline hemoglobin and hematocrit to 7.1/22 respectively from baseline 10s/32-33.No obvious source of bleeding was found.No reported gi bleeding, but mentioned to other physician that stool was dark.The patient was hospitalized on (b)(6) 2020.The patient had pain primarily in right lower abdomen and flank, was nauseated and itchy, and was dry heaving in bed.The patient was examined and found to have diminutive non-bleeding mallory-weiss tear with no stigmata of recent bleeding, hematin (altered blood/coffee-ground like material in the gastric fundus), normal examined duodenum.No pancreatic duct stent was found.The treatment plan for the patient was to administer proton pump inhibitors orally, twice a day, for 30 days.The patient was administered hydromorphone to treat pain, and was also given anti-nauseants during her stay.On (b)(6) 2020, the patient's hemoglobin levels were 6.9.The patient was given a transfusion with 1 unit of packed red blood cells (prbc).The bleed was reported to be resolved.Renal ultrasound showed hydronephrosis and some debris, with no ureteral tear or forniceal rupture.Hydronephrosis, retroperitoneal inflammation was determined to be from post ercp pancreatitis.On (b)(6) 2020, a right ureteral stent was placed.On (b)(6) 2020, the patient was reevaluated.Nausea was controlled, and abdominal pain improved.The patient continued to experience flank pain, and was managed well with current treatment plan.On (b)(6) 2020, the patient was reevaluated.The abdomen/pelvis were viewed under ct and showed a large rim-enhancing fluid collection in the retroperitoneum on the right extends from the kidney down into the pelvis.According to the physician, these findings could be related to pancreatitis, trauma, or nonspecific abscess.On (b)(6) 2020, the patient's pain was reported to be worse.On (b)(6) 2020, the patient had a percutaneous drain placed for complex right perinephric abscess.The patient was discharged on (b)(6) 2020.The patient's condition was noted to be improved at the time of discharge.

• Brand Name: JAGWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10707867
• MDR Text Key: 213242765
• Report Number: 3005099803-2020-04831
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-P-JAGWIRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 64 YR