MAUDE Adverse Event Report: COOK ENDOSCOPY TRACER METRO DIRECT WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G25686

Device Problems Peeled/Delaminated (1454); Positioning Problem (3009); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

Non- health care professional.Concomitant medical products: sphincterotome/catheter; unknown make or model, metal stent; unknown make or model.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 wire guide subassembly device history record was performed.A discrepancy or anomaly was not observed.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: coating damage on the wire guide contributed to loss of wire guide access.However, we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the wire guide coating damage observation could not be determined.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.If the endoscope or accessory device used with this device contains a burr, this could contribute to wire guide coating separation/damage.Prior to distribution, all cook tracer metro direct wire guides are subjected to a visual inspection 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 Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook tracer metro direct wire guide.The coating of the wire got damaged.The following additional information was received on 30-oct-2018: the wire guide was placed over a catheter/sphincterotome and left in the bile duct.A metal stent was advanced over the wire guide, but could not be advanced fully as it got stuck.Everything was removed [lost wire guide access].Damage and stripping of the coating of the wire guide was visible.Placement of a new wire guide and finished procedure with this new device.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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook tracer metro direct wire guide.The coating of the wire got damaged.The following additional information was received on (b)(6) 2018, the wire guide was placed over a catheter/sphincterotome and left in the bile duct.A metal stent was advanced over the wire guide, but could not be advanced fully as it got stuck.Everything was removed [lost wire guide access].Damage and stripping of the coating of the wire guide was visible.Placement of a new wire guide and finished procedure with this new device.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 from section e3: non- health care professional.Continued from section d11: sphincterotome/catheter; unknown make or model, metal stent; unknown make or model.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.There is wire guide coating damage on the spiral coating.The distal 16.7 cm of wire guide is bent with a kink 16.7 cm from the distal end.From 22.0 cm to 38.5 cm from the distal end, the wire guide coating feels very rough with a couple sections of bare core wire.Specifically, the core wire is exposed 27.5 cm - 28.6 cm and 36.0 cm - 38.3 cm from the distal end.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A review of the wire guide subassembly device history record was performed.A discrepancy or anomaly was not observed.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: coating damage on the wire guide contributed to loss of wire guide access.However, 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.If the endoscope or accessory device used with this device contains a burr, this could contribute to wire guide coating separation/damage.Prior to distribution, all cook tracer metro direct wire guides are subjected to a visual inspection 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: TRACER METRO DIRECT WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8095057
• MDR Text Key: 129338703
• Report Number: 1037905-2018-00541
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002256866
• UDI-Public: (01)00827002256866(17)201219(10)W4008805
• 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: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2020
• Device Model Number: G25686
• Device Catalogue Number: METII-35-480
• Device Lot Number: W4008805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS DUODENSOCOPE, UNKNOWN MODEL