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

Model Number G47617

Device Problems Peeled/Delaminated (1454); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: cook echotip ultra high definition ultrasound access needle, echo-hd-19-a.Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.A product evaluation performed with the pictures provided confirmed the report.Along a bend at the distal end, there is a section of bare core wire.The section of the coating is separated from the wire guide from approximately 6 cm to 17 cm, the coating is still attached at either end.A few sections of the coating are frayed and hanging from the wire guide.Our laboratory evaluation of the product said to be involved further confirmed the report.The wire guide was returned inside the racetrack.Upon visual inspection, there is wire guide coating damage near the distal end.The distal tip of the is angled up to 1.2 cm.Approximately 5.9 cm to 6.7 cm and 6.9 cm to 17.0 cm from the distal end are sections of bare core wire.A section of the coating approximately 10.1 cm long is frayed and hanging from the wire guide, the coating still attached at either end of the separated section.A section of the coating approximately 0.9 cm long is hanging from the wire guide, the coating is still attached at approximately 6.7 cm from the distal end.A section of the coating approximately 1.2 cm long is frayed and hanging from the wire guide, the coating still attached at approximately 16.6 cm from the distal end.There is a bend in the core wire approximately 9.1 cm from the distal end.No kinks are found along the wire guide.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 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: the report states that this incident occurred while using this product with an echo-hd-19-a.This is the most likely cause for the reported observation.The instructions for use for this product line caution the user: "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." the instructions for use state the following as the intended use for this device: "this device is used to assist in cannulation of the biliary and pancreatic ducts and to aid in bridging difficult strictures during ercp." the instructions for use state, "do not use this device for any other purpose other than stated intended use." the report indicates that the wire guide was used with an eus device.Prior to distribution, all cook acrobat 2 calibrated tip 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 and this represents an isolated 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 repot: based on the information provided that the device was used a metal tip ercp device in an off label procedure, 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.The wire guide peeled while being use with a cook echotip ultra high definition ultrasound access needle (echo-hd-19-a).The following additional information was received on 29-june-2018: after advancing the acrobat wire through the access needle and reaching the bile duct, they needed to withdraw and move the wire guide in order to gain access to the papilla.This is when the problems [wire guide coating damage] began.The pictures provided by the user show coating damage approximately 6 cm to 17 cm from the distal 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
• 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: 7709890
• MDR Text Key: 114714077
• Report Number: 1037905-2018-00330
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002476172
• UDI-Public: (01)00827002476172(17)201025(10)W3931198
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2018

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: 10/25/2020
• Device Model Number: G47617
• Device Catalogue Number: AWG2-35-450-A
• Device Lot Number: W3931198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PENTAX EG3870UTK ENDOSCOPE