MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX PANCREATIC STENT KIT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00537350
Medical Device Problem Codes	Entrapment of Device (1212); Problem with Sterilization (1596)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: 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 supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangiopancreatography procedure in the duodenum on (b)(6) 2019.According to the complainant, on (b)(6) 2019, upon deploying the advanix pancreatic stent in the duodenum, the physician was unable to view the stent through the endoscope and under fluoroscopy.The physician looked around and could not locate the stent, so it was assumed that the stent was lost and the procedure was completed with another stent.After the procedure, the endoscope underwent the cycle of decontamination and disinfection.A few days later, on an unknown date, the same endoscope was used during a new endoscopic retrograde cholangiopancreatography procedure on a different patient.A tome was passed through the scope and it was noticed that the stent from the previous procedure began to exit the distal end of the scope into the new patient.Once this was visualized, the scope was withdrawn from the patient and the stent was removed completely.There were no patient complications reported as a result of this event.

• Brand Name: ADVANIX PANCREATIC STENT KIT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8392593
• Report Number: 3005099803-2019-01016
• Device Sequence Number: 13834154
• Product Code: FGE
• UDI-Device Identifier: 08714729856344
• UDI-Public: 08714729856344
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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
• Operator of Device: Health Professional
• Device Model Number: M00537350
• Device Catalogue Number: 3735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention