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); Test Result (2695)

Event Type  Injury  

Event Description

A physician reported via a literature article pertaining to a retrospective chart review that a (b)(6) female received deflux (dextranomer microspheres/hyaluronic acid) injection into the submucosa of the urinary bladder as treatment for grade 3 vesicoureteral reflux to a transplanted kidney.Additional medical history included renal transplantation of a cadaveric donor kidney three years prior, febrile urinary tract infections, and a high and wide orifice in the right bladder wall on cystoscopy.Concurrent medications were not provided.On an unk date, the pt received deflux, 3 x 0.3 ml (0.9 ml total) to the transplanted kidney in a combined hydrodistention-implantation technique (hit) and subureteral transurethral injection technique (sting).Perioperative prophylaxis was given.Within 5 days serum creatinine rose from 120 to 250 mol/l.An ultrasound showed hydronephrosis and a ureteral stent was placed 10 days after the injection.After that, a slow regression of the serum creatinine was seen and the hydronephrosis resolved.The stent was removed 4 months later and ultrasound follow-up 5 weeks later showed no obstruction.The authors concluded that the incidence of ureteral obstruction complication was higher than previously reported in the literature.In addition, in relation to endoscopic treatment in transplanted kidneys, the authors were of the opinion that scarring at the site of ureteral anastamosis (decreased tissue compliance) and location for the transplant ureteral orifice were relevant for endoscopic treatment.Both scarring and position of the ureteral orifice could cause incorrect placement of deflux deposits and thus constitute risk factors for obstruction.Report received from q-med.The company assessed the events as possible related to deflux.

• Brand Name: DEFLUX
• Type of Device: AGENT, BULKING, INJECTABLE
• Manufacturer (Section D): Q-MED AB; uppsala ; SW
• Manufacturer (Section G): Q-MED AB; seminariegatan 21; uppsala SE-7 52 2; SW SE-752 28
• Manufacturer Contact: 8510 colonnade center drive; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 4468399
• MDR Text Key: 5182495
• Report Number: 3009325614-2015-00006
• 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
• 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

• 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
• Date Report to Manufacturer: 01/20/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2015
• 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: 10 YR