MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. RE-ENTRY MALECOT CATHETER; CATHETER, NEPHROSTOMY

Catalog Number M001224110

Device Problems Break (1069); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 07/15/2014

Event Type  malfunction  

Event Description

Surgeon observed by fluoroscopy that a "re-entry malecot nephrostomy catheter" was broken into two pieces during a "percutaneous second look nephrostolithotomy of the right kidney".The catheter had been placed a week ago.Op report: " the patient had a 16 french re-entry nephrostomy tube which appeared to be discontinuous on fluoroscopy with a gap of about 2 cm.An antegrade pyelogram confirmed this to be the case with the break in the retroperitoneum, although there was contrast going through the tract into the distal portion of the catheter and into the renal pelvis.A 0.35 glidewire was placed through the existing nephrostomy tract and into the renal pelvis and the outer portion of the nephrostomy tube was removed.The flexible cystoscope was placed and the retained portion of the nephrostomy tube was encountered.An attempt was made to engage this within a stone basket; however, this was unsuccessful in extracting the stent.A second guidewire was placed and negotiated down the ureter into the bladder.A dual lumen catheter was placed over this wire and a the initial wire was negotiated down the ureter as well.The dual lumen catheter was removed.One wire was left in place as a safety wire.A balloon dilator was placed over the working wire and the tract was easily dilated back to 30 french.The access sheath was then placed over the balloon and the dilator was then removed.The rigid nephroscope was then placed and the end of the retained nephrostomy tube was eventually engaged with graspers and was removed.As the tube was removed, the sheath and guidewire were dislodged as well.Both parts of the tube were kept for analysis".
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manufacturer response for 16fx35cm re-entry malcot catheter, (brand not provided) (per site reporter)
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the or staff contacted the rep and the rep arranged to return the catheter to the manufacturer for investigation.

• Brand Name: RE-ENTRY MALECOT CATHETER
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.; one boston scientific place; natick MA 01760 153
• MDR Report Key: 3979268
• MDR Text Key: 21729131
• Report Number: 3979268
• Device Sequence Number: 1
• Product Code: LJE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2014

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: Invalid Data
• Device Catalogue Number: M001224110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 52