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

Model Number	32337
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal part of the suture broke and was unable be removed.A stenosed target lesion was located at mildly tortuous and moderately calcified biliary tract.A vtcb/8.3 flexima was selected for used.The catheter was attempted to withdraw after few days of drainage.During withdrawal, it was reported that the distal part of the catheter locking string was unable to be removed.It was remained inside the patient's body.There were no patient's complications reported.
Event or Problem Description
It was reported that the distal part of the suture broke and was unable be removed.A stenosed target lesion was located at mildly tortuous and moderately calcified biliary tract.A vtcb/8.3 flexima was selected for used.The catheter was attempted to withdraw after few days of drainage.During withdrawal, it was reported that the distal part of the catheter locking string was unable to be removed.It was remained inside the patient's body.There were no patient's complications reported.It was further reported that there were no additional interventions done to removed the disconnected suture.The patient's condition post-procedure was stable.
Additional Manufacturer Narrative
This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/17/2018 10:09 am ct.The report number is being corrected from: 2134265-2018-64297 to: 2134265-2018-62215.
Event or Problem Description
It was reported that the distal part of the suture broke and was unable be removed.A stenosed target lesion was located at mildly tortuous and moderately calcified biliary tract.A vtcb/8.3 flexima was selected for used.The catheter was attempted to withdraw after few days of drainage.During withdrawal, it was reported that the distal part of the catheter locking string was unable to be removed.It was remained inside the patient's body.There were no patient's complications reported.It was further reported that there were no additional interventions done to removed the disconnected suture.The patient's condition post-procedure was stable.Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the proximal section (pigtail) was found to be buckled/accordion and the suture string was returned broken.No other anomalies or damages were encountered.

• Brand Name: FLEXIMA
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7995731
• Report Number: 2134265-2018-62215
• Device Sequence Number: 18882391
• Product Code: FGE
• UDI-Device Identifier: 08714729454953
• UDI-Public: 08714729454953
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K023870
• 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,Followup,Followup
• Report Date (Section B): 01/25/2019

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: 04/25/2021
• Device Model Number: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0022043560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018; 12/06/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/09/2018; 01/25/2019
• 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: Other
• Patient Age: 48 YR