MAUDE Adverse Event Report: COOK ENDOSCOPY ACROBAT® 2 CALIBRATED TIP WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G47610

Device Problems Peeled/Delaminated (1454); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: cook classic ercp catheter, ercp-1-bt.Occupation: non-healthcare professional.The product was returned for evaluation and 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 an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat® 2 calibrated tip wire guide.[it was] difficult to pass through [the catheter] and the end peeled off the wire guide.The physician was using a cook classic ercp catheter [ercp-1-bt].Finally this one [wire guide] was peeled [coating damage].The physician used another wire guide from another manufacturer and it worked well.Additional information was received on 19-mar-2019 indicating that the damage on the wire guide was at the patient end, 5 centimeters from the tip.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

Cook classic ercp catheter, ercp-1-bt.Occupation: non-healthcare professional.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.From the tip to approximately 0.3 cm from the distal end, the wire guide covering has accordioned.Approximately 0.3 cm to 1.1 cm from the distal end, the wire guide covering has stretched thin.Approximately 4.1 cm to 5.9 cm from the distal end, 7.1 cm to 8.1 cm from the distal end, and 8.7 cm to 9.0 cm from the distal end are sections of bare core wire.A section of the coating approximately 3.0 cm long is hanging from the wire guide, the coating is still attached at approximately 6.5 cm and 8.6 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.The device history records for the wire guide lot was reviewed.The wire guide device history record contains nonconformances that could potentially be related to wire guide damage.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: the event description states that the wire guide was used with a ercp-1-bt catheter, which is a metal tipped device.Per the instructions for use: "use of this wire guide with metal tip ercp devices may result in damage to the external coating and/or tip of the wire guide." use with the incompatible metal tipped device is the most likely root cause.Prior to distribution, all acrobat® 2 calibrated tip 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 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.Additional comments regarding this report: based on the information provided that the acrobat 2 wire guide was used with a metal tipped device, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat® 2 calibrated tip wire guide.[it was] difficult to pass through [the catheter] and the end peeled off the wire guide.The physician was using a cook classic ercp catheter [ercp-1-bt].Finally this one [wire guide] was peeled [coating damage].The physician used another wire guide from another manufacturer and it worked well.Additional information was received on 19-mar-2019 indicating that the damage on the wire guide was at the patient end, 5 centimeters from the tip.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.

• Brand Name: ACROBAT® 2 CALIBRATED TIP 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: 8471382
• MDR Text Key: 146518079
• Report Number: 1037905-2019-00161
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002476103
• UDI-Public: (01)00827002476103(17)220114(10)W4166625
• 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: 03/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Model Number: G47610
• Device Catalogue Number: AWG2-25-450
• Device Lot Number: W4166625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 04/01/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJF-Q180 ENDOSCOPE.