FDA Adverse Event Injury Summary report: N

HIWIRE NITINOL HYDROPHILIC WIRE GUIDE

MDR report key: 3240285 · Received July 18, 2013

Report

Report Number: 1820334-2013-00312
Event Type: Injury
Date Received: July 18, 2013
Date of Event: June 18, 2013
Report Date: June 18, 2013
Manufacturer: COOK, INC.
Product Code: OCY
PMA / PMN Number: K082536
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DUE TO THE COMPLAINT DEVICE NOT BEING RETURNED A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. A REVIEW OF THE SPECIFICATIONS INDICATES THE ORDER WAS PROCESSED ACCORDING TO PROCEDURES. THE EVALUATION RESULTS ARE INCONCLUSIVE; THE ROOT CAUSE OF THE CUSTOMER'S DIFFICULTY COULD NOT BE DETERMINED; HOWEVER, THE COMPLAINT WAS CONFIRMED BASED UPON THE CUSTOMER'S STATEMENT. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS IS THE FIRST COMPLAINT OF THIS KIND. INSUFFICIENT RISK DUE IN PART TO LOW SEVERITY AND HIGH DETECTABILITY.

Description of Event or Problem · 1

THE PHYSICIAN STATED THAT THE HIWIRE NITINOL HYDROPHILIC WIRE GUIDE TIP WENT THROUGH THE RIGHT RENAL PELVIS. WHEN THE COOK REPRESENTATIVE ASKED THE PHYSICIAN IF THIS MIGHT HAVE HAPPENED WITH ANY GUIDE WIRE-TYPE WIRE WITH THAT 5CM TIP OR IF THERE WAS POSSIBLY SOMETHING DIFFERENT ABOUT THE PT'S ANATOMY, THE PHYSICIAN WAS NOT SURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
333292	HIWIRE NITINOL HYDROPHILIC WIRE GUIDE	OCY ENDOSCOPIC GUIDEWIRE, GASTROENTERGOLOGY-UROLOGY	OCY	COOK, INC.	NA	10080934

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other