MAUDE Adverse Event Report: COOK INC HIWIRE NITINOL HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Surgical procedure, additional (2564); No Code Available (3191)

Event Date 01/29/2015

Event Type  Injury  

Event Description

Per report (b)(4): a male patient was brought into surgery for right chest tube insertion and tunneled dialysis catheter insertion.After the chest tube insertion, the patient was re-prepped and re-draped for the dialysis catheter insertion.As the guide wire was pulled back, the sharp tip of the needle shredded the coating of the guide wire and a piece was left in the patient's vein.The retained piece of the guide wire was removed.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Maude report # (b)(4).Event evaluation: a review of complaint history and instructions for use (ifu) was conducted during the investigation.The hiwire nitinol hydrophilic wire guide was not returned for investigation.The wire guide with lot number 10416153 was made to specification.The customer stated "the sharp tip of the needle shredded the coating of the wire guide" and the ifu states "avoid manipulation or withdrawing the hydrophilic wire guide back through a metal needle or cannula.A sharp edge may scrape the coating or shear the wire guide.A catheter, introducer sheath or vessel dilator should replace the needle as soon as the wire guide has been inserted in the vessel." based on the customers testimony the root cause is failure of customer to follow the ifu.We will continue to monitor for similar complaints.(b)(4).

Event Description

Per report (b)(4): a male patient was brought into surgery for right chest tube insertion and tunneled dialysis catheter insertion.After the chest tube insertion, the patient was re-prepped and re-draped for the dialysis catheter insertion.As the guide wire was pulled back, the sharp tip of the needle shredded the coating of the guide wire and a piece was left inside the patient's vein.The retained piece of the guide wire was removed.A section of the device did not remain inside the patient's body.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: HIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4925823
• MDR Text Key: 6434909
• Report Number: 1820334-2015-00458
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2015,06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Model Number: N/A
• Device Catalogue Number: HWA-035150
• Device Lot Number: 10416153
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2015
• Distributor Facility Aware Date: 01/29/2015
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 07/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 117