MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA CATHETER; TUBE, DRAINAGE, SUPRAPUBIC

Model Number 30895

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date reported as (b)(6) 2019.

Event Description

It was reported that the sutures from a drainage catheter were left in the patient.A 6f flexima all purpose drainage catheter was selected for use for biliary drainage.The drainage catheter was left in the patient for five and half months.During removal of the drainage catheter, the sutures were not entirely removed and remained in the patient.The suture was located near the liver, in a superficial location.Very little of the suture was left in the patient, and one attempt was made to remove the suture.The drain was removed with difficulty due to encrustation and age.No adverse effects to the patient were reported.

• Brand Name: FLEXIMA CATHETER
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol,; alajuela ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8940955
• MDR Text Key: 155932002
• Report Number: 2134265-2019-10313
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K023870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30895
• Device Catalogue Number: 30895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other