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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device returned advanced into a cook oasis device, believed to be the oa-8.5 the customer referenced using during the procedure.The distal end of the wire guide is bent/kinked approximately 5.8cm from the distal tip.There is wire guide coating damage near the distal end.A section of the coating has peeled, and the core wire was exposed approximately 26.9cm to 27.7cm from the distal end.No portion of the coating appears to be 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: our evaluation of the returned device confirmed the report of wire guide coating damage.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 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 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) procedure, the physician used a cook acrobat calibrated tip wire guide.It was reported that the physician planned to implant a stent in a patient.The physician attempted to utilize cook tri-25m sphincterotome along with acro-35-450 wire guide to reach common bile duct.The physician flushed the wire guide and wire lumen of the tri-25m with saline and soaked the wire guide with gauze with saline before advancing into wire guide lumen.The physician took five (5) minutes to reach the common bile duct with the tri-25m and acro-35-450 wire guide and detected there around a 2cm long shadow on radiography image at the lower common bile duct, then the physician attempted to dilate upper common bile duct.The physician slightly cut the duodenal papilla with tri-25m device, then retracted the tri-25m device from patient, flushed the sbdc-8.5 dilation catheter device lumen and advanced sbdc-8.5 through the wire guide to bile duct to dilate.After dilation, the physician retracted the sbdc-8.5 from the patient and attempted to place 8.5fr (7cm long) stent and found out the coating of the wire guide had peeled off from endoscopy view [subject of report].The physician retracted the wire guide immediately and changed to metii-35-480 wire guide and placed the stent through metiii-35-480 wire guide successfully.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): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 16015804
• MDR Text Key: 307016568
• Report Number: 1037905-2022-00705
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2022

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-35-450
• Device Lot Number: W4614140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2022
• 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: COOK OA-8.5 STENT INTRODUCTION SYSTEM; COOK SBDC-8.5 DILATION CATHETER; COOK TRI-25M SPHINCTEROTOME; COOK TTSO-8.5-8 STENT; PENTAX DUODENOSCOPE, MODEL UNKNOWN
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 66 KG