MAUDE Adverse Event Report: COOK INC OPEN-END FLEXI-TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign body, removal of (2365); No Code Available (3191)

Event Date 05/18/2015

Event Type  Injury  

Event Description

During a procedure on a female patient, the tip of the catheter fell off within the uterus.All pieces of the device were retrieved with forceps.According to the initial, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is still under investigation at this time.

Manufacturer Narrative

(b)(4).

Event Description

During a procedure on a female patient, the tip of the catheter fell off within the uterus.All pieces of the device were retrieved with forceps.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation- evaluation: a review of the complaint history, device history record, quality control (qc), specifications, and a visual inspection of the complaint device has been conducted for the purpose of this investigation.The product was returned in an opened and used condition.A visual inspection noted that the distal tip of the catheter had separated.The break appeared to be a clean break and did not exhibit any elongation.The device history records indicated that the product met pull test requirements.Qc inspection for this device states: "assure tip is round and smooth." / "check for smoothness of bond." pull testing is completed.Specifications states that "material shall be uniform in quality and condition, clean, smooth, and free from foreign materials, lumps, tears, die marks, excessive waviness, or striations.Incoming qc shall verify that material conforms to specifications.Based on this evaluation, we are inconclusive as to why this failure mode occurred.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

During a procedure on a female patient, the tip of the catheter fell off within the uterus.All pieces of the device were retrieved with forceps.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• 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: 4827929
• MDR Text Key: 5910623
• Report Number: 1820334-2015-00342
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 021305
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2014
• 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