MAUDE Adverse Event Report: COOK INC ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/11/2017
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 the wire guide in an ultrathane wills-oglesby single lumen percutaneous gastrostomy set was placed backwards in the set when packaged.This was reportedly discovered when the needle was inserted percutaneously into the stomach, followed by the guidewire, and then a 7 french dilator.The guidewire was then removed, and contrast media was injected into the stomach.This showed a perforation of the stomach wall, which was then confirmed via x-ray imaging.Upon removal of the guidewire by the operator, it was discovered that the stiff end of the guidewire had been inserted first, rather than the floppy tip, which would have been expected.The tract was then dilated up, and a gastrostomy tube was placed.The operator checked the position of the tube, and then the patient was returned to the ward.The patient restrictions for food and drink following surgery were each extended an additional 24 hours.
Additional Manufacturer Narrative
Additional information received identified the patient's stomach perforation was treated conservatively-no treatment and the patient recovered as expected with no complications.It was also clarified that the patient was initially admitted to the hospital for gastrostomy insertion and has an underlying disease of recurrent tongue cancer.Per the customer, "the patient is alive at present although his underlying malignancy is progressing.His gastrostomy is said to be functioning well.He has had no further treatments." corrected data: occupation.Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, manufacturing instructions, specifications, quality control, and trends of the device was conducted during the investigation.The device history record (work order number (b)(4)) was reviewed and confirmed that no nonconformances were recorded.Since the wogs-1200, ultrathane wills-oglesby single lumen percutaneous gastrostomy set is supplied with component parts, the device history record for ic375222 regarding the complaint device thsf-38-125-thg was reviewed and confirmed there were two nonconformances not related to this failure mode.These nonconformances were scrapped prior to further processing of the order.To date, a further search of the manufacturer's database records revealed this complaint to be the only reported complaint associated to the complaint lot number (7580747).It was stated that a patient's stomach was perforated with the wire guide in the wogs set due to the wire guide being loaded backwards.Retraining was performed for the operator in question.The actual root cause of this complaint is manufacturing related ¿ operator related, as the perforation was caused by the backwards loading of the wire.This failure mode is being escalated per internal processes.A field action has been initiated as a result of this failure mode/event.

• Brand Name: ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6813758
• Report Number: 1820334-2017-02543
• Device Sequence Number: 969795
• Product Code: KNT
• UDI-Device Identifier: 00827002052741
• UDI-Public: (01)00827002052741(17)200201(10)7580747
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: No Information
• Device Model Number: N/A
• Device Catalogue Number: WOGS-1200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1820334-16OCT2017-014-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 DA