MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UNK-P-ADVANIX_PANCREATIC; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00535060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 pancreatic stent placement procedure in the pancreatic duct, performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician attempted to deploy the stent, it was observed that the stent was torn/ broken.Stenosis was not significantly narrow.The stent was successfully deployed and completed the procedure.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.
Additional Manufacturer Narrative
Block h6: device code 1069 captures the reportable event of stent break.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.Block h11: correction to d1: brand name; d2: common device name; d4: model number, lot number, catalog number, expiration date, unique identifier (udi) #.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during a pancreatic stent placement procedure in the pancreatic duct, performed on (b)(6) 2020.According to the complainant, during the procedure, when the physician attempted to deploy the stent, it was observed that the stent was torn/broken.Stenosis was not significantly narrow.The stent was successfully deployed and completed the procedure.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: UNK-P-ADVANIX_PANCREATIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10326591
• Report Number: 3005099803-2020-02920
• Device Sequence Number: 11565576
• Product Code: FGE
• UDI-Device Identifier: 08714729856221
• UDI-Public: 08714729856221
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

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: 08/29/2021
• Device Model Number: M00535060
• Device Catalogue Number: 3506
• Device Lot Number: 0025289490
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1