MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00545570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
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.(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 a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct.The exact event date was not reported.According to the complainant, during the procedure, when the stent was deployed, the guide catheter was dislodged from the push catheter.A snare was used to remove the broken guide catheter.The procedure was successfully completed with the original flexima biliary stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct.The exact event date was not reported.According to the complainant, during the procedure, when the stent was deployed, the guide catheter was dislodged from the push catheter.A snare was used to remove the broken guide catheter.The procedure was successfully completed with the original flexima biliary stent.There were no patient complications reported as a result of this event."the patient was undergoing an ercp in the endoscopy suite.The device was introduced and according to staff,"the stent was deployed and (the ) transducer on (the) stent fell off into (the) patient".The transducer was quickly retrieved with no harm coming to the patient.".
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Block f10; h6: problem code 1069 captures for the reportable event of guide catheter broken.Block h6: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: 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.Block a3: patient's sex: updated to female.Block g3; h10: user facility reference number: (b)(4).

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9078829
• Report Number: 3005099803-2019-04576
• Device Sequence Number: 16757319
• Product Code: FGE
• UDI-Device Identifier: 08714729337874
• UDI-Public: 08714729337874
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K965147
• 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,Followup
• Report Date (Section B): 10/18/2019

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 Expiration Date: 04/03/2021
• Device Model Number: M00545570
• Device Catalogue Number: 4557
• Device Lot Number: 0021945512
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/18/2019
• 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