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

Model Number	M00536520
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 based on the date the manufacturer became aware of the event.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.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 a procedure.The procedure date was not reported.According to the complainant, during the procedure, when the physician attempted to deploy the stent, it was noticed that the stent was kinked.The stent was removed and the procedure was successfully completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: ADVANIX PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10749302
• Report Number: 3005099803-2020-04955
• Device Sequence Number: 19598184
• Product Code: FGE
• UDI-Device Identifier: 08714729857464
• UDI-Public: 08714729857464
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2021
• Device Model Number: M00536520
• Device Catalogue Number: 3652
• Device Lot Number: 0024581323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1