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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(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.This report accounts for one of three events reported by the customer.Reference mdr report numbers 1820334-2017-00379, 1820334-2017-00380 and 1820334-2017-00374 for all associated reports.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
International customer reported that a chait percutaneous cecostomy catheter was leaking.The date of the event was not provided.The date of initial implant is not known.Additional event and patient information was requested.No further information was received.It is opined that the device required replacement.The instructions for use that accompany each device provides precautions that "the catheter should be changed every 6 months to reduce the risk of catheter fracture in the patient." instructions for catheter exchange state " introduce an appropriate wire guide.Through the chait trapdoor cecostomy catheter and into the cecum.Remove catheter leaving wire guide in place.Introduce new chait trapdoor cecostomy catheter over wire guide and advance into position.".
Additional Manufacturer Narrative
Investigation summary: a review of the complaint history, device history record, documentation, instructions for use, manufacturing instructions, and quality control data was conducted during the investigation.The manufacturing documents available at the time of manufacture were reviewed and it was found that the device elements in question (trapdoor plug, trapdoor assembly, bond between the trapdoor assembly and the catheter, and the catheter itself) were all visually inspected by quality control, and that the bond between the fitting & the catheter and the fit between the plug & the trapdoor were both inspected via physical pull test.The risk specification for this device includes the failure mode ¿leakage¿ and identified that multiple risk controls were in place to mitigate the risk of this type of failure.The device history record was reviewed and no related non-conformances were identified.A search of our complaint records indicates that this was the only complaint on this lot number.The product was not returned.Possible root causes of this event are catheter fatigue, bond failure between the catheter and trapdoor, or inadequate fit between the plug and trapdoor, however based on the limited information provided a root cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• 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: 6395939
• Report Number: 1820334-2017-00374
• Device Sequence Number: 1001860
• Product Code: KNT
• UDI-Device Identifier: 00827002116320
• UDI-Public: (01)00827002116320(17)190314(10)6810654
• Combination Product (Y/N): N
• PMA/510(K) Number: K982500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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
• 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: 02/09/2017
• Supplement Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention