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

Model Number G22139

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Perforation (2001)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Investigation evaluation: our evaluation of the product said to be involved was unable to confirm the report of perforation as it was described.We were able to confirm a device failure which may have contributed to the perforation.The wire guide is kinked in the coil spring section, approximately 5.7 cm from the distal end.Orange/brown discoloration was found on the coil spring and coil spring joint.While it is uncertain whether these observations occurred during use or transport, without substantial evidence to contradict the complaint it is considered confirmed based solely on 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: based on our evaluation of the returned device, the wire guide was kinked in the area of the coil spring.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 coil spring 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.

Event Description

During an esophagogastroduodenoscopy (egd) procedure, the physician used a cook savary-gilliard wire guide.There was a bleed.The following additional information was received on 09 september 2018: the patient was scheduled and arrived for egd under monitored anesthesia care as an outpatient procedure.The procedure was performed without report of clinical difficulty.The patient progressed to post operation progressive recovery with stable vital signs and given cola to drink when awake.The patient then began to complain of pain in the right abdomen radiating to the rear.The bowel sounds were quiet, and the abdomen was tight.The physician was notified and saw the patient.An acute abdominal series was completed in x ray.The patient then complained of nausea.The physician then informed the patient of a perforation.The acute abnormal series showed significant pneumoperitoneum.A surgeon was consulted, and the patient was medicated for pain and nausea and antibiotics were started.The patient was then transferred via air helicopter to another hospital.The patient's vital signs were stable with increase in blood pressure with pain.The device was evaluated and determined to have a kink /bend in the patient end of the wire.A section of the device did not remain inside the patient¿s body.The patient was found to have a perforation and was medicated for pain and nausea and given antibiotics.The patient was then transferred to another facility and required an exploratory laparotomy.

• 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 (Section G): 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: 7909776
• MDR Text Key: 121754150
• Report Number: 1037905-2018-00441
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002221390
• UDI-Public: (01)00827002221390(17)200726(10)W3894992
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2020
• Device Model Number: G22139
• Device Catalogue Number: SGW-200-SD
• Device Lot Number: W3894992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: COOK SAVARY- GILLARD DILATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 95