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

Model Number G57280

Device Problem Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Occupation: non-healthcare professional.The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.

Event Description

During a dilation procedure, the physician used a cook savary-gilliard wire guide.The physician was dilating a stricture and noted the wire was "not going down", so he pulled it out and found that the wire was bent.The procedure was completed with a reusable wire guide.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

Event Description

During a dilation procedure, the physician used a cook savary-gilliard wire guide.The physician was dilating a stricture and noted the wire was "not going down", so he pulled it out and found that the wire was bent.The procedure was completed with a reusable wire guide.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Continued: section e.Occupation: non-healthcare professional.Investigation evaluation: our laboratory evaluation of the returned product confirmed the report of a bend in the wire.The rigid section of the wire guide was bent at the 113cm area as measured from the proximal tip of the wire guide.The returned wire guide also had a severe 90° kink in the coil spring section at the transition from the rigid section of the wire to the flexible section of the wire.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 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.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 also 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.".Prior to distribution, all savary-gilliard wire guides are subjected to a visual inspection and functional testing 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.

• Brand Name: SAVARY-GILLIARD WIRE GUIDE
• Type of Device: KNQ, ESOPHAGEAL DILATOR
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 9641649
• MDR Text Key: 220825174
• Report Number: 1037905-2020-00045
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 00827002572805
• UDI-Public: (01)00827002572805(17)221101(10)W4281430
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: G57280
• Device Catalogue Number: SGW-200-SD-D
• Device Lot Number: W4281430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MAKE OR MODEL.
• Patient Age: 76 YR
• Patient Weight: 80