MIC G-16 INTRODUCER KIT 98422-17

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-08 for MIC G-16 INTRODUCER KIT 98422-17 manufactured by Kimberly-clark.

Event Text Entries

[1418421] Pt had gastrostomy tube placed in an interventional radiology setting using the kimberly-clark telescoping dilator in 2009. As the device was removed from the pt, the three -non-radiopaque- dilators came off the end of the device and were retained in the pt's stomach unk to the proceduralist. The pt required a ct scan for other issues six months later, where the retained dilator was noted. The pt needed endoscopy the next day for removal of the object. The pt did not experience any harm. The kimberly-clark sales rep stated, when notified of the event, that the company has since event month, modified this device in order to diminish the risk of this issue occurring. No notification was received of potential safety issues or product modification. We have continued to use this product until the event discovery. All pts that this device was used on are now having charts and scans reviewed and if unable to confirm no retained foreign objects, they will be notified to be evaluated. Dates of use: 2009. Diagnosis or reason for use: gastrostomy tube placement. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5014284
• MDR Report Key: 1577546
• Date Received: 2010-01-08
• Date of Report: 2010-01-08
• Date of Event: 2009-07-06
• Date Added to Maude: 2010-01-19
• 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: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MIC G-16 INTRODUCER KIT
• Generic Name: TELESCOPING DILATOR
• Product Code: KDH
• Date Received: 2010-01-08
• Model Number: 98422-17
• Lot Number: AA9033R02
• Device Expiration Date: 2011-02-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: KIMBERLY-CLARK
• Manufacturer Address: ROSWELL GA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2010-01-08