MAUDE Adverse Event Report: COOK, INC. FALLOPIAN TUBE CATHETERIZATION SET; LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE

Catalog Number FTC-550-NT

Device Problem Material Separation (1562)

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Date 11/20/2014

Event Type  Injury  

Event Description

Tip of catheter was broken when physician inserted the device into the body.The pieces of broken catheter couldn't be removed from the patient's body and be rushed into abdominal cavity.A section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

A review of the complaint history, device history record, instructions for use (ifu), quality control (qc) and a visual inspection of the returned opened and used product was conducted during the course of our investigation.The visual inspection noted that the distal tip of the catheter had separated from the shaft.The remaining portion of the tip/shaft also demonstrated a tear where a portion of the shaft was missing, possibly due to excessive force imaging was also provided and shows where the tip remained in the patient's abdominal cavity.This product is shipped with an instructions for use (ifu) which states warnings, precautions and instructions for use.Based on the information provided and the results of our investigation, it is feasible to suggest that the root cause was product use/handling related as the product received excessive pressure.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment, no further action is required appropriate internal personnel have been notified and monitoring for similar complaints continues.

Event Description

The tip of the catheter was broken when physician inserted the device into the body.The pieces of the broken catheter could not be removed from the patient's body and was rushed into the abdominal cavity.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: FALLOPIAN TUBE CATHETERIZATION SET
• Type of Device: LKF CANNULA, MANIPULATOR/INJECTOR, UTERINE
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4335998
• MDR Text Key: 5242611
• Report Number: 1820334-2014-00649
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 00827002109926
• UDI-Public: (01)00827002109926(17)160901(10)4491600
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K955508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: FTC-550-NT
• Device Lot Number: 4491600
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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): Other
• Patient Age: 47 YR