MAUDE Adverse Event Report: COOK INC ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Inflammation (1932); 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, approximately 1 week following the uneventful insertion of a percutaneous radio-guided gastrostomy, an opening occurred at the periphery of the gastrostomy orifice.Leakage of the gastric fluid and inflammation of the patient's cutaneous skin were reported.The gastrostomy feeding tube was exchanged for a larger sized feeding tube in an attempt to restore the seal at the gastrostomy site.Antibiotics, skin care, and proton pump inhibitors were administered.Clinical monitoring was performed as a precaution, and the usage of this device was reportedly halted by the customer temporarily.It is not known whether or not the device will be returned; as of the date of this report, no device has yet been received for evaluation.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: reports 1820334-2017-03798, 1820334-2017-03799, 1820334-2017-03800, 1820334-2017-03801 were reported to cook inc.By (b)(6) on behalf of (b)(6) for 4 separate occurrences of the same malfunction.510(k): preamendment corrected information: age, date of birth; implant date.Investigation - evaluation a review of the complaint history, drawings, device history record, manufacturing instructions, specifications, and quality control was conducted during the investigation.No systemic issues were found related to the reported complaint.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record of the finished product shows no nonconforming events.It should also be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.The results of the investigation led to the conclusion that no further action is warranted for this failure mode.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ENTUIT START INITIAL PLACEMENT GASTROSTOMY SET
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7007588
• Report Number: 1820334-2017-03800
• Device Sequence Number: 1298474
• Product Code: KNT
• UDI-Device Identifier: 00827002344433
• UDI-Public: (01)00827002344433(17)200216(10)7683360
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

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: IPSG-M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 01/31/2018
• 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
• Patient Age: 5 MO