FLEXI-NEEDLE 15 GA 25 CM * 5615

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-16 for FLEXI-NEEDLE 15 GA 25 CM * 5615 manufactured by Liberty Medical.

Event Text Entries

[15188939] The pt's diagnosis was adenocarcinoma of the prostate, gleason score vii, psa 12. 4. He underwent a procedure for interstitial prostate brachytherapy via high dose rate. Twelve catheters and obturators were loaded into the prostate volume. Once treatment was complete the catheters are to be removed. Two of the plastic catheters broke off and the ends were retrieved. The third catheter broke off and surgeon was unable to retrieve. It was noted that some of the obturators used did not have the rounded end they were sharp and squared off. The theory is that the sharp edges of the obturators may have cut the catheters when they were inserted. The statement by the representative at liberty medical was that perhaps the obturators were assembled by the mfr improperly, that maybe the sharp end should have been glued into the handle.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1038052
• MDR Report Key: 686137
• Date Received: 2006-02-16
• Date of Report: 2006-02-16
• Date of Event: 2006-01-26
• Date Added to Maude: 2006-03-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: FLEXI-NEEDLE 15 GA 25 CM
• Generic Name: CATHETER/NEEDLE
• Product Code: IWJ
• Date Received: 2006-02-16
• Model Number: *
• Catalog Number: 5615
• Lot Number: 14341
• ID Number: *
• Device Expiration Date: 2006-09-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 675360
• Manufacturer: LIBERTY MEDICAL
• Manufacturer Address: * ASHBURN VA 20147 US

Device Sequence Number: 2

• Brand Name: OBTURATOR
• Generic Name: CATHETER/NEEDLE
• Product Code: IWJ
• Date Received: 2006-02-16
• Model Number: *
• Catalog Number: 5615
• Lot Number: 14341
• ID Number: *
• Device Expiration Date: 2006-09-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 675362
• Manufacturer: LIBERTY MEDICAL
• Manufacturer Address: * ASHBURN VA 20147 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2006-02-16