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

Model Number	M00536540
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(6).(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during a procedure, performed on (b)(6) 2020.According to the complainant, it was noticed that the seal attached in the sterile pouch was opened upon inspection.The packaging seal was stuck on the pusher.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: 9889559
• Report Number: 3005099803-2020-01304
• Device Sequence Number: 14013216
• Product Code: FGE
• UDI-Device Identifier: 08714729857488
• UDI-Public: 08714729857488
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/22/2021
• Device Model Number: M00536540
• Device Catalogue Number: 3654
• Device Lot Number: 0024332778
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 03/27/2020
• Patient Sequence Number: 1