PERCUFLEX 6 FR X 26CMS DJ STENT LIST# 145-128

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-29 for PERCUFLEX 6 FR X 26CMS DJ STENT LIST# 145-128 manufactured by Microvasive.

Event Text Entries

[17822590] The patient, a 78 year old male, was admitted for removal of a retained left double j stent. The stent was inserted march 21, 1994 at time of turp. Attempt to remove the stent by cystoscopy was unsuccessful may 13, 1994, due to the stent's migration, secondary to extreme dilatation of the ureter. (the distal end of the left ureteral stent coiled in the region of the distal ureter and superior pigtail end of the stent within the upper collecting system. ) stent removed 6/2/94, utilizing a nephroscope and grasping forceps. A nephrostomy tube was inserted at that time. Patient tolerated procedure well. Product still available for manufacturer's qa testing. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 20906
• MDR Report Key: 20906
• Date Received: 1994-08-29
• Date of Report: 1994-07-26
• Date of Event: 1994-06-02
• Report Date: 1994-07-26
• Date Added to Maude: 1995-03-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PERCUFLEX 6 FR X 26CMS DJ STENT
• Product Code: MER
• Date Received: 1994-08-29
• Model Number: LIST# 145-128
• Lot Number: 112743
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 20805
• Manufacturer: MICROVASIVE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1994-08-29