MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC ACROBAT CALIBRATED TIP WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number ACRO-35-450

Device Problem Peeled/Delaminated (1454)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/13/2014

Event Type  Injury  

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat calibrated tip wire guide.The hydrophilic coating has become detached during stent placement.The coating was retrieved and another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient's body.Other than retrieving the detached coating, the patient did not require any additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: our evaluation of the returned device confirmed the report.There is an approximately 18 cm from the distal end is an approximately 1.5 cm section of bare core wire.The coating is frayed and a section approximately 0.7 cm long is hanging from the proximal side of the bare core wire.It appears that a section approximately 1 cm long is missing.There is a kink in the wire guide approximately 3 cm from the distal end.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 conclusions: 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.The instructions for use for this product line instruct the user to flush the wire guide prior to removal from the wire guide holder.This activity will aid in optimal performance of the wire guide.Failure to flush the wire guide can result in damage to the wire guide.The instruction for use for this product line instruct the user to flush endoscope accessory channel and/or lumen of device with sterile water and for best results, wire guide should be kept wet.This activity will aid in optimal performance of the wire guide.Failure to flush the endoscope channel can result in damage to the wire guide.The instructions for use for this product cautions the user that this product is compatible with non-metal tip devices.Use of the wire guide with metal tip devices may compromise the integrity of the external coating on the wire guide.The reported observation can occur if the wire guide was used with an incompatible accessory device.If additional pressure is applied to the wire guide and/or accessory devices(s) while moving the wire guide inside the accessory devices(s), this could contribute to wire guide coating damage.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: corrective action is not warranted at this tie 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: ACROBAT CALIBRATED TIP WIRE GUIDE
• Type of Device: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, manager ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4380002
• MDR Text Key: 15319810
• Report Number: 1037905-2014-00500
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K122816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2017
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W3478636
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/13/2014
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/28/2014
• Initial Date FDA Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2014
• 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: GALLENGANGS PROTHESE PUSHER-KATHETER; ENDOFLEX 11CM STENT; ENDOFLEX 7CM STENT; ERCP KATHETER ENDOFLEX; OLYMPUS TJF 180V ENDOSCOPE; WIEDERWENDBARER PUSHER
• Patient Outcome(s): Required Intervention