MAUDE Adverse Event Report: COOK ENDOSCOPY PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL; KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	G22636
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report because the product said to be involved was not provided to cook for evaluation.Per the photos provided, we cannot complete a full evaluation.The photo appears to be of an cook peg-24 feeding tube, snare, blue pull wire and a pouch from the lot number provided in the report.The label matches the product and accessories shown in the photo.Our evaluation of the photos provided with the report confirmed the report.The looped wire appears to have been pulled out of the feeding tube dilator remaining attached to the blue pull wire.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos provided and the statements describing the event.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.The instructions for use (ifu) indicates, "using the enclosed scalpel, make a one (1) cm long incision through the skin, subcutaneous tissue.Caution: a smaller incision may contribute to extreme resistance of the gastrostomy feeding tube when exiting the fascia." the ifu states, "warning: excessive traction on the gastric feeding tube may cause premature removal, fatigue or failure of the device." the ifu indicates, "using water-soluble lubricant and gauze, thoroughly lubricate the dilator and entire external length of the tube including the internal bumper." inadequate lubrication of the feeding tube prior to placement could contribute to excessive pressure and subsequent feeding tube damage.Prior to distribution, all peg 24 percutaneous endoscopic gastrostomy set - pulls are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During an esophagogastroduodenoscopy (egd), the physician used a cook peg 24 percutaneous endoscopic gastrostomy set (pull).During the process of pulling the feeding tube outside the stoma, the feeding tube's loop knotted to the loop insertion wire was detached from the feeding tube.Observing the loop that was detached from the tube, it was cleaning [cleanly] detached from the tube without exerting a lot of effort during the pulling technique.The peg was inserted but the metallic loop connected to guide wire (blue) was detached during a pull through process.It states that a section did remain in the patients body and that it was retrieved with the endoscope and snare.The communication receive on 5/16/2017 states: we initially committed to replace two (2) units.One that got detached and one that was opened, but the patient's relative decided to transfer to a different hospital and use a different brand thus it was not used.
Additional Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the report.Only the feeding tube and blue pull wire were provided with the return.The looped wire appears to have been pulled out of the feeding tube dilator after separating from the metal cannula.Some of the coating on the distal end of the blue pull wire has been pulled away exposing the inner cable.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.The looped wire is within specification.The loop wire remains attached to the blue pull wire and the metal cannula remains inside of the feeding tube dilator.For further evaluation, the feeding tube was cut to reveal the proximal end of the dilator.Glue was present between the feeding tube/dilator, on the proximal end of the dilator, and on the proximal end of the cannula.Some of the glue was removed and the cannula was then pushed out of the proximal end of the dilator for dimensional verification.The cannula appears to have been crimped.When measured with calipers, the cannula has an outer diameter (od) which is within specifications.The certificate of compliance provided by the supplier was reviewed.The supplier verifies the cannula joint.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use (ifu) states, "warning: excessive traction on the gastric feeding tube may cause premature removal, fatigue or failure of the device." the ifu indicates, "using water-soluble lubricant and gauze, thoroughly lubricate the dilator and entire external length of the tube including the internal bumper." inadequate lubrication of the feeding tube prior to placement could contribute to excessive pressure and subsequent feeding tube damage.Prior to distribution, all peg 24 percutaneous endoscopic gastrostomy set - pulls are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
The following was initially provided on 6/8/2017: "during an esophagogastroduodenoscopy (egd), the physician used a cook peg 24 percutaneous endoscopic gastrostomy set (pull).During the process of pulling the feeding tube outside the stoma, the feeding tube's loop knotted to the loop insertion wire was detached from the feeding tube.Observing the loop that was detached from the tube, it was cleaning [cleanly] detached from the tube without exerting a lot of effort during the pulling technique.The peg was inserted but the metallic loop connected to guide wire (blue) was detached during a pull through process.It states that a section did remain in the patient's body and that it was retrieved with the endoscope and snare.The communication received on 5/16/2017 states: we initially committed to replace two (2) units.One that got detached and one that was opened, but the patient's relative decided to transfer to a different hospital and use a different brand thus it was not used." the following clarification was received on 7/4/2017: there were no sections of the device that detached or became free inside of the patient, there was no need to use a snare to retrieve the device.There is no complaint related to the second device that was opened but not used.

• Brand Name: PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PULL
• Common Device Name: KNT, TUBE, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 6621970
• Report Number: 1037905-2017-00363
• Device Sequence Number: 788527
• Product Code: KNT
• UDI-Device Identifier: 00827002226364
• UDI-Public: (01)00827002226364(17)171115(10)W3797879
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K920703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G22636
• Device Catalogue Number: PEG-24-PULL-S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/12/2017
• Device Age: 5 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCOPE UNKNOWN MAKE OR MODEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR