MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION ULTRA SHORT WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	G31910
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product was returned in an open pouch from lot number w4041055.The label matches the product returned.Our evaluation of the product determined that there was coating damage to the device.Bare core wire was present approximately 5.5 cm to 6.0 cm, 152.8 cm to 153.1 cm, 153.5 cm to 154.8 cm, 161.0 cm to 161.6 cm, and 162.8 cm to 163.0 cm from the distal end.A section of the coating approximately 0.2 cm long was frayed and hanging from the wire guide, with the coating attached at approximately 5.8 cm from the distal end.A section of the coating approximately 0.3 cm long was frayed and hanging from the wire guide with the coating attached at approximately 151.1 cm from the distal end.A section of the coating approximately 0.9 cm long was frayed and hanging from the wire guide with the coating attached at approximately 155.1 cm and 156.0 cm from the distal end.A section of the coating approximately 0.6 cm long was frayed and hanging from the wire guide, with the coating attached at approximately 161.0 cm and 161.6 cm from the distal end.The wire guide coating was damaged approximately 152.5 cm to 152.8 cm from the distal end, however no bare core wire was present.The wire guide covering felt rough approximately 20.8 cm to 21.4 cm, 160.2 cm to 160.6 cm, and 184.8 cm to 185.6 cm from the distal end.The wire guide covering was bent approximately 18 cm to 26 cm and 160 cm to 167 cm from the distal end.Due to the condition of the returned device, it cannot be determined if any sections of the coating were missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all fusion ultra short 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 or Problem Description
During an endoscopic procedure, the physician used a cook fusion ultra short wire guide.A complaint form for multiple devices was received 05/08/2019 with a cook fusion ultra short wire guide listed.There was no description provided for this device, therefore there was no reportable information at that time.A cook fusion ultra short wire guide was received for evaluation on 05/13/2019 and found to have coating damage at 5 - 6.2 cm with the core wire exposed.There was no complaint reported on the returned wire guide; however, the wire guide was returned with a bag of multiple other devices.The description of event for the related devices [different reference part numbers] states that the "coating in some cases loosens and possibly makes entry difficult [coating damage], for example during stent introduction." the related mdrs were reported under 1037905-2019-00220 and 1037905-2019-00221.A section of the device did not remain inside the patients 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 these occurrences.

• Brand Name: FUSION ULTRA SHORT WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8666725
• Report Number: 1037905-2019-00306
• Device Sequence Number: 11288438
• Product Code: OCY
• UDI-Device Identifier: 00827002319103
• UDI-Public: (01)00827002319103(17)210315(10)W4041055
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2019

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 Expiration Date: 03/15/2021
• Device Model Number: G31910
• Device Catalogue Number: FSW-35
• Device Lot Number: W4041055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/04/2019
• 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