MAUDE Adverse Event Report: COOK INC CHAIT PERCUTANEOUS CECOSTOMY CATHETER; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that they experienced difficulty removing the chait tube off of the stiffened cannula of a chait percutaneous cecostomy catheter.The removal of the existing chait tub was reportedly uneventful, but when the foley was removed and the new chait tube was placed over the wire on the stiffened cannula, the difficulties were experienced.Eventually it could be removed; however, the 5 minute procedure was extended to 45 minutes, and the patient reported discomfort.The device is reportedly not available for return.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The clinical investigation cites the ifu, noting that the catheter should be replaced every 6 months to reduce the risk of catheter fracture in the patient.The customer claimed that they change them every 12-18 months, thus it is possible that this contributed to the complaint.Without a returned device, the clinical investigation cannot rule out manufacturing related, user technique, off-label use, product handling, or human anatomy.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The appropriate personnel have been notified and cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: CHAIT PERCUTANEOUS CECOSTOMY CATHETER
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7022462
• Report Number: 1820334-2017-03928
• Device Sequence Number: 19095461
• Product Code: KNT
• UDI-Device Identifier: 00827002116320
• UDI-Public: (01)00827002116320(17)190705(10)7094799
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K982500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TDCS-100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 03/12/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention