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

Catalog Number ACRO-35-205

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: electrosurgical generator, unknown make and model.Cook fusion cytology brush, fs-cb-1.5-s.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.Approximately 2.9 cm to 8.1 cm and 26.8 cm to 28.3 cm from the distal end, the wire guide covering has folded over itself.Approximately 8.6 cm to 26.8 cm from the distal end is a section of bare core wire.A section of the coating approximately 18.1 cm long is frayed and hanging from the wire guide, the coating is still attached at approximately 2.9 cm from the distal end.Another section of the coating approximately 1.4 cm long is frayed and hanging from the wire guide, the coating is still attached at approximately 28.3 cm from the distal end.Approximately 28.3 cm to 29.0 cm from the distal end, the wire guide covering has accordioned.The wire guide tip is bent approximately 10 cm from the distal end.The wire guide is bent approximately 18 cm to 34 cm, 152 cm to 155 cm, and 165 cm to 171 cm from the distal end.A few rough surfaces are found throughout the entire length of the wire guide, notably at approximately 152 cm to 155 cm and 165 cm to 171 cm from the distal end.A review of the device history record could not be conducted because the lot number was not provided.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 acrobat® calibrated tip wire guides are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: 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 acrobat calibrated tip wire guide.It was originally reported that an acrobat 2 calibrated tip wire guide was used.The customer stated that the wire guide began to strip off, possibly the hydrophilic coating whilst inside the patient.The stripping happened at the patient end approximately 25 cm from the tip.A fusion cytology brush was placed over the wire guide.The doctor experienced resistance on removal of the cytology brush.There was no reportable information at this time.The additional questions received on 26-jul-2019 state that a new wire guide and brush were used to complete the procedure [lost wire guide access].The device was received on 01-aug-2019.The device returned was an acro-35-205.The device returned with damage consistent to what was reported in the complaint as well as with a copy of the complaint form and a fusion cytology brush.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¿ 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: 8912498
• MDR Text Key: 155088146
• Report Number: 1037905-2019-00479
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2019

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 Catalogue Number: ACRO-35-205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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