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

Model Number G47616

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 03/25/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: cook soehendra biliary dilation catheter, unknown reference part number endoscopic ultrasound needle 19 gauge, unknown manufacturer and reference part number investigation evaluation: our evaluation of the product said to be involved confirmed the report.Approximately 0.3 cm to 0.7 cm from the distal end, the wire guide has accordioned.Approximately 0.7 cm to 4.0 cm from the distal end, the wire guide covering has stretched thin and the wire guide has bent.Approximately 4.0 cm to 10.9 cm from the distal end was a section of bare core wire.A section of the coating approximately 4.0 cm long was frayed and hanging from the wire guide, the coating still attached at approximately 10.9 cm from the distal end.Rough surfaces are found throughout the entire length of 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 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 report states that this incident occurred while using this product with an eus needle.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 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 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 this wire guide was used off label with a metal tip eus device, a cook representative has contacted 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 ultrasonography (eus), the physician used a cook acrobat® 2 calibrated tip wire guide.The wire guide was placed through an eus (endoscopic ultrasound) 19 gauge access needle for a rendezvous case to get into the pancreatic duct [off label].After access was achieved, the needle was removed and they tried to place a soehendra biliary dilation catheter over the wire guide and it would not go over the wire guide because the wire guide had stripped.They had to abandon the case.The wire guide stripped around the 10 cm to the 6 cm mark.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: 8529147
• MDR Text Key: 151130189
• Report Number: 1037905-2019-00203
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002476165
• UDI-Public: (01)00827002476165(17)220107(10)W4163743
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2019

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: 01/07/2022
• Device Model Number: G47616
• Device Catalogue Number: AWG2-35-450
• Device Lot Number: W4163743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2019
• 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