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

Model Number M001235510

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone number: (b)(6).

Event Description

It was reported that the string was cut and remained inside the patient's body.The treatment area was in a ureter.A percuflex ureteral catheter stent was selected for use.During procedure, after the stent has been deployed to the desired area, it was noted that the stent would also pull back while trying to remove the strings even when pressure was applied on the opposite direction.The physician decided to cut the strings at the skin; however, a portion of the string was left inside the patient's body.The procedure was completed, but the strings were left inside the patient.No further patient complications reported and the patient's condition was stable.

• Brand Name: PERCUFLEX
• 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.; coyol ; CS
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8128398
• MDR Text Key: 129171123
• Report Number: 2134265-2018-63311
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001235510
• Device Lot Number: 21892180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2018
• 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