MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ADVANIX¿ PANCREATIC STENT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00536370
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.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 in an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, on (b)(6) 2018, while the endoscope was being pre-cleaned and brushed in preparation for a procedure, an advanix pancreatic stent came out of the working channel as the cleaning brush was being pushed down the biopsy channel.The stent was not introduced into the patient during the procedure, and it is suspected that the stent was lodged in the scope before the procedure had started.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Following the procedure, the patient was given a phone call and was informed of the potential risk of infection due to the device issue.There was no further action reported for this patient.No treatment or hospital stay were reported due to this incident.

• Brand Name: ADVANIX¿ PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7698450
• Report Number: 3005099803-2018-02234
• Device Sequence Number: 16392794
• Product Code: FGE
• UDI-Device Identifier: 08714729857310
• UDI-Public: 08714729857310
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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): 06/21/2018

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: M00536370
• Device Catalogue Number: 3637
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 07/18/2018
• 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: Other