MAUDE Adverse Event Report: Q-MED AB DEFLUX; AGENT, BULKING, INJECTABLE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Obstruction/Occlusion (2422); Abdominal Distention (2601)

Event Type  Injury  

Event Description

A physician reported via a literature article pertaining to a retrospective chart review that a (b)(6) male received deflux (dextranomer microspheres/hyaluronic acid) injection into the submucosa of th urinary bladder as treatment for left grade 2 vesicoureteral reflux (vur).Additional medical history included an open dismembered pyeloplasty with double-j stent insertion for uteropelvic junction obstruction (upjo).Concurrent medications were not provided.On an unk date, the pt received deflux, 2 x 0.5ml (1 ml total) utilizing the subureteral transurethral injection technique (sting).Deflux was injected at the time of double-j stent removal, three months following the pyeloplasty.Perioperative prophylaxis was given along with four weeks of antibiotics.Persistent hydroureteronephrosis on ultrasonography and a loss of 10 percent in differential function on mag-3 renography 3 months later led to placement of a double-j stent.At the time of stent placement a retrograde pyelogram showed a wide ureteropelvic anastomosis.The stent was removed 5 months later and the last ultrasound performed 9 months after the stent removal showed no dilatation.The authors concluded that the incidence of ureteral obstruction complication was higher than previously reported in the literature.In addition, the authors were of the opinion that injection therapy at the time of catheter removal after pyeloplasty may predispose to obstruction as well.Report received from q-med.The company assessed the events as possibly related to deflux.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; appsala ; SW
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala SE-7 52-2; SW SE-752-28
• Manufacturer Contact: 8510 colonnade center dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 4468377
• MDR Text Key: 5181956
• Report Number: 3009325614-2015-00003
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P000029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2015,01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2015
• Distributor Facility Aware Date: 01/08/2015
• Device Age: 3 MO
• Date Report to Manufacturer: 01/20/2015
• Date Manufacturer Received: 01/08/2015
• 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): Required Intervention
• Patient Age: 6 MO