MAUDE Adverse Event Report: BOSTON SCIENTIFIC FLEXIMA APDL LOCKING PIGTAIL; CATHETER, NEPHROSTOMY

Model Number 08714729323105

Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Code Available (3191)

Event Date 05/24/2017

Event Type  Injury  

Event Description

Nephrostomy tube failure, 8 french x25 cm flexima apdl locking pigtail into the left kidney.When the straightening dilator was removed, it stripped out.A more intensive procedure needed to be completed.A 9 fr pull away sheath was inserted over the tube, the old tube was removed.A 10 fr x25 cm flexima drainage tube was inserted without further incident.The device was saved and it appears as there is an extra piece of clear plastic was inside the tube and appears to be a mfr's defect.Mfr was notified.On (b)(6) 2016 nephrostomy tube injection left, impression: nephrostomy tube in satisfactory position with no dilated left renal pelvicalyceal-proximal and proximal-mid left ureteric system.Abrupt discontinuity (possible transection) of the mid distal left ureter at the level of the mid sacrum with contrast flowing towards the mid pelvis at the level and extending toward indwelling right lateral pelvic drainage catheter.

• Brand Name: FLEXIMA APDL LOCKING PIGTAIL
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC; 2546 first street propark; el coyol, alajuela, cr ; CS
• MDR Report Key: 6593590
• MDR Text Key: 76154060
• Report Number: MW5070033
• Device Sequence Number: 1
• Product Code: LJE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Model Number: 08714729323105
• Device Catalogue Number: M001271340
• Device Lot Number: 19880189
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 52