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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Urinary Tract Infection (2120); Vomiting (2144); Rupture (2208); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

A physician reported via a literature article pertaining to a retrospective chart review that an 11 months old female received deflux (dextranomer microspheres/hyaluronic acid) injection into the submucosa of the urinary bladder as treatment for left grade 3 vesicoureteral reflux (vur).Additional medical history included hydronephrosis that was detected prenatally, uteropelvic junction obstruction (upjo), febrile urinary tract infection, and laparoscopic pyeloplasty with double-j stent insertion.Concurrent medications were not provided.On an unk date, four weeks after the pyeloplasty, the pt received deflux, 1 ml, at the time of stent removal and utilizing the subureteral transurethral injection technique (sting).Perioperative prophylaxis was given along with four weeks of antibiotics.After another pyelonephritis, 7 months later, a repeated voiding cystourethrogram (vucg) revealed bilateral vur grade ii.For that reason, a second injection with 1 ml was performed.A few hours after this second injection, she developed abdominal pain and vomiting.She was watched closely and treated symptomatically.Five days after the injection, imaging studies (ultrasonogram and intravenous pyelography) showed urinary extravasation around the kidney interpreted as a rupture of the renal pelvis.Therefore, she received a percutaneous nephrostomy that was left in place for 12 days.At the time of nephrostomy removal there was no evidence of ureteral obstruction.A mag-3 renography 2 months later revealed no obstruction.Despite persistence of grade i reflux, the child is well 3 years later and a dmsa scan showed no scars.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 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 dr; raleigh, NC 27615 ; 9198621000
• MDR Report Key: 4468374
• MDR Text Key: 5185219
• Report Number: 3009325614-2015-00002
• 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: 7 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: 11 MO