MAUDE Adverse Event Report: COOK ENDOSCOPY SAVARY-GILLIARD WIRE GUIDE; KNQ, DILATOR, ESOPHAGEAL

Catalog Number SGW-200-SD

Device Problem Bent (1059)

Patient Problem Perforation of Esophagus (2399)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.A review of the device history record could not be conducted because the lot number was not provided.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.Based on the customer's report the guide wire was bent at a severe angle at the top of the flexible tip.Perforation is identified as a potential complication in the instructions for use.Placement of the wire guide in the correct location is critical to avoid kinking the wire guide and assuring correct dilation.The instructions for use provides the following caution statement, "caution: continuous fluoroscopic monitoring of wire guide is essential in order to ensure it remains in proper position." the wire guide is a reusable device.It is unknown how many times the product was reused.The instructions for use states "during cleaning, inspect integrity and function of device to determine advisability of reuse.If kinks, bends or breaks exist, do not use." prior to distribution, all savary-gilliard wire guides are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted and this represents an unusual occurrence.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 Description

The following was reported on 6/9/2017 from the user facility: during an upper gastrointestinal endoscopy, the physician used a cook savary-gilliard wire guide.The patient visited the endoscopy unit for an elective upper gastrointestinal (gi) endoscopy related to esophageal dysphasia.The patient's esophagus was noted to be so small the endoscope could not pass through and there was a web.The non-owned provider made the decision to dilate the esophagus at this time.The dilator was being passed over the guide wire and resistance was felt.The provider pulled all instrumentation out and went back to look and noted there was a false passage highly suspicious for perforation.The procedure was aborted immediately.At this time it was noted the guide wire was bent at a severe angle at the top of the flexible tip.The patient is currently admitted in stable condition but more testing and evaluation is needed to determine what intervention may need to take place.The customer confirmed on 6/13/2017 that it was the wire guide that malfunctioned.Nothing broke off in the patient.No further information is available.The following was received on 6/22/2017 from medwatch mw5070265: patient was in our endoscopy unit for an elective upper gi endoscopy due to dysphasia.The patient's esophagus was found to have a web and be very small so dilation was attempted.As the dilator was being passed over the savary wire guide there was resistance felt by the provider.The instruments were pulled out and a false passage was noted upon inspections.At this time it was noted the guidewire was bent at a severe angle at the top of the flexible tip and looked to be fragile.The patient was positive for perforation which is being treated conservatively to this point with antibiotics and npo [nothing by mouth] status.

Manufacturer Narrative

Pictures of the complaint device were received on 6/30/2017.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 photos indicate the distal tip of the wire guide is kinked near the proximal end of the coil spring.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos provided.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: based on the provided photos the wire guide was kinked in the area of the coilspring.It is possible the kink contributed to the reported perforation.Placement of the wire guide in the correct location is critical to avoid kinking the wire guide and assuring correct dilation.Specifically, per the instructions for use: "when wire guide is in position well beyond strictured area." contacting the coilspring end of the wire guide with the dilator may result in kinking.The instructions for use provides the following caution statement: "caution: continuous fluoroscopic monitoring of wire guide is essential in order to ensure it remains in proper position." perforation is identified as a potential complication in the instructions for use.The wire guide is a reusable device.It is unknown how many times the product was reused.The instructions for use states: "during cleaning, inspect integrity and function of device to determine advisability of reuse.If kinks, bends or breaks exist, do not use." prior to distribution, all savary-gilliard wire guides are subjected to a visual inspection and functional testing to ensure device integrity.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.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 photos indicate the distal tip of the wire guide is kinked near the proximal end of the coil spring.Without the product or substantial evidence to contradict the complaint, it is considered confirmed based solely on the photos provided.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: based on the provided photos the wire guide was kinked in the area of the coilspring.It is possible the kink contributed to the reported perforation.Placement of the wire guide in the correct location is critical to avoid kinking the wire guide and assuring correct dilation.Specifically, per the instructions for use: "when wire guide is in position well beyond strictured area." contacting the coilspring end of the wire guide with the dilator may result in kinking.The instructions for use provides the following caution statement: "caution: continuous fluoroscopic monitoring of wire guide is essential in order to ensure it remains in proper position." perforation is identified as a potential complication in the instructions for use.The wire guide is a reusable device.It is unknown how many times the product was reused.The instructions for use states: "during cleaning, inspect integrity and function of device to determine advisability of reuse.If kinks, bends or breaks exist, do not use." prior to distribution, all savary-gilliard wire guides are subjected to a visual inspection and functional testing to ensure device integrity.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.

• Brand Name: SAVARY-GILLIARD WIRE GUIDE
• Type of Device: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6678788
• MDR Text Key: 78788077
• Report Number: 1037905-2017-00437
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/25/2017,07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SGW-200-SD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2017
• Distributor Facility Aware Date: 05/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2017
• Date Manufacturer Received: 06/30/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR