MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY NEPHROMAX¿; CATHETER, NEPHROSTOMY

Model Number M0062101170

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Damage (2104)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter was used in the kidney during a percutaneous nephrolithotomy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, tip of the sheath and other parts of the balloon becomes rough and bruised causing damage to the tissue at the subcutaneous and kidney entry area.The procedure was completed with a amplatz type renal dilator device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

Investigation results: a visual examination of the complaint device revealed no visible damage on the tip section of the sheath.Functional analysis was performed; the mandrel passed the sheath without resistance.No kinks or damage was noted along the entire length of the sheath.Therefore the root cause for this complaint cannot be confirmed.

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter was used in the kidney during a percutaneous nephrolithotomy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, tip of the sheath and other parts of the balloon becomes rough and bruised causing damage to the tissue at the subcutaneous and kidney entry area.The procedure was completed with a amplatz type renal dilator device.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.

• Brand Name: NEPHROMAX¿
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6084963
• MDR Text Key: 59337746
• Report Number: 3005099803-2016-03492
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: K952968
• 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,Followup
• Report Date: 10/24/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2019
• Device Model Number: M0062101170
• Device Catalogue Number: 210-117
• Device Lot Number: 18955461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention