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	10/11/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal part of the suture broke and remained inside patient.The target lesion was located in the mildly tortuous and moderately calcified biliary tract.A vtcb/8.3 flexima was selected for use.The catheter was attempted to withdraw after a few days of drainage.During withdrawal, it was noted that the distal part of the suture detached somewhere inside the patient's body and was unable to be withdrawn.The separated suture was then tried to pulled out by hand and by forcep but it could not be removed.After withdrawal od the flexima catheter and the remaining suture inside, the proximal part of the suture was cut by scissor and the procedure was ended.No further patient complications were reported and patient's status was stable.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.The unit returned has a catheter damaged, as part of overall visual revision.The device returned with the metal cannula loaded, the device and metal cannula looks in good condition.However, the cannula was observed with residues at distal end.Dimensional inspection of the outer diameter and length were performed and were within specifications.Functional inspection was performed and revealed that the metal cannula was withdraw without resistance and its was inserted again through the device and no resistance was felt.Additionally, a mandrel of 0.038" was inserted through the metal cannula and no resistance was felt.
Event or Problem Description
It was reported that the distal part of the suture broke and remained inside patient.The target lesion was located in the mildly tortuous and moderately calcified biliary tract.A vtcb/8.3 flexima was selected for use.The catheter was attempted to withdraw after a few days of drainage.During withdrawal, it was noted that the distal part of the suture detached somewhere inside the patient's body and was unable to be withdrawn.The separated suture was then tried to pulled out by hand and by forcep but it could not be removed.After withdrawal od the flexima catheter and the remaining suture inside, the proximal part of the suture was cut by scissor and the procedure was ended.No further patient complications were reported and patient's status was stable.

• 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: 8005695
• Report Number: 2134265-2018-62287
• Device Sequence Number: 19120348
• 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
• Report Date (Section B): 01/03/2019

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: 04/15/2021
• Device Model Number: 32337
• Device Catalogue Number: 32337
• Device Lot Number: 0021994657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 01/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR