FDA Adverse Event Injury Summary report: N

FLEXIMA CATHETER

MDR report key: 1820023 · Received August 30, 2010

Report

Report Number: 2134265-2010-03996
Event Type: Injury
Date Received: August 30, 2010
Report Date: August 3, 2010
Manufacturer: BOSTON SCIENTIFIC - SPENCER
Product Code: FFA
PMA / PMN Number: K944290
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A URETERAL STENTING TREATMENT PROCEDURE, THE PIGTAIL FORMED IN THE URETER RATHER THAN THE BLADDER. THE PHYSICIAN ATTEMPTED PLACING A FLEXIMA US/8/24 STENT AND DIDN'T REALIZE THERE WAS AN OBSTRUCTION AT THE DISTAL END OF THE URETER. DUE TO THE PATIENT ANATOMY, THE DISTAL END OF THE PIGTAIL TOOK SHAPE IN THE DILATED URETER RATHER THAN THE BLADDER. THE PHYSICIAN HAD DIFFICULTY KNOWING THE POSITION OF THE DISTAL PIGTAIL PRIOR TO REMOVING THE CANNULA AND GUDE WIRE. THE CANNULA OR GUIDE WIRE COULD NOT BE REINSERTED TO ADVANCE THE SYSTEM DISTALLY. THE PHYSICIAN USED A PEEL AWAY SHEATH, TOOK THE SUTURE AND GENTLY PULLED ON THE SHEATH TO REMOVE THE ENTIRE SYSTEM. THE PATIENT WAS LATER SENT TO SURGERY. NO PATIENT HARM WAS NOTED AND THE PATIENT'S STATUS IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FLEXIMA CATHETER	TUBE, DRAINAGE, SUPRAPUBIC	FFA	BOSTON SCIENTIFIC - SPENCER	M001274020

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention