MAUDE Adverse Event Report: COOK INC. KWART RETRO-INJECT; STENT, URETERAL

Model Number AQ-003600

Device Problems Physical Resistance (2578); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2015

Event Type  malfunction  

Event Description

Patient underwent a cystoscopy and retrograde pyelogram with left ureteral stent.After passing the inserter over the wire guide and pushing it into the end of the stent, the stent was advanced into the renal pelvis under fluoroscopic guidance.An attempt was then made to disengage the stent from the inserter by passing the release sleeve.It was noted that the release sleeve would not slide over the inserter easily.The release sleeve met much resistance.The ureteral stent was placed by an alternate method.

• Brand Name: KWART RETRO-INJECT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK INC.; 750 daniels way; bloomington IN 47402
• MDR Report Key: 4732492
• MDR Text Key: 17933269
• Report Number: 4732492
• Device Sequence Number: 0
• Product Code: FAD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: AQ-003600
• Device Lot Number: 5584315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2015
• Patient Sequence Number: 0
• Patient Age: 34 YR
• Patient Weight: 87