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 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a white plastic bag, provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.Coating damage was noted at 21.7cm to 22.5cm from the distal tip with the core wire exposed.Under magnification the coating appeared torn with a yellowish substance within the torn area.The joint connecting the distal tip and proximal wire guide was smooth and undamaged.A small frayed segment was noted 280.3cm from the distal tip.A bend was present 24.1cm from the distal tip.The 5 band marker has been worn off on one side of the wire guide.No other anomalies were detected with the device.The device history record does contain a nonconformance that could potentially be related to the reported observation.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.Investigation conclusion: our evaluation of the product said to be involved confirmed the report of 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 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 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 advanced the duodenoscopy to duodenal papilla, then flushed the wire guide lumen of sphincterotome, and flushed the wire guide with saline and soaked with gauze before entering into the sphincterotome wire guide lumen.User took around five (5) minutes to advance the sphincterotome device through duodenal papilla, then detected there was 1cm linear stenosis in lower common bile duct after radiography.User then cut the duodenal papilla with sphincterotome, then retracted the sphincterotome device and left the wire guide in place.User flushed the lumen of dilation catheter device as well as soaked with gauze, then advanced the dilation catheter through wire guide to bile duct to conduct dilation.After dilation user retracted the dilation catheter device.User flushed the wire guide lumen of endoscopic catheter with saline, then advanced the catheter through wire guide to desired position to conduct examination and obtain the biopsy.User retracted the endoscopic catheter afterward, but user observed the coating of wire guide 22cm from distal end peel off under endoscopic view.[coating damage] user retracted the wire guide and changed to another wire guide to continue the procedure [loss of wire guide access].User took the wire guide along with sphincterotome to get access to duodenal papilla, then left the wire guide in place, then advanced the stent delivery system through wire guide (8.5fr and 7cm long christmas tree stent) and placed the stent in desired position to complete the procedure.Additional information was received on 29 mar 2024 stating that no biopsy was obtained, only inspection through endoscope.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: 19143092
• MDR Text Key: 341473594
• Report Number: 1037905-2024-00221
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002342665
• UDI-Public: (01)10827002342665(17)260721(10)W4747984
• 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: 04/19/2024

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: W4747984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2023
• 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 METII-35-480 WIRE GUIDE; COOK SBDC-9 DILATION CATHETER; COOK TRI-25M SPHINCTEROTOME; PENTAX DUODENOSCOPY, MODEL UNKNOWN; RYAN SUTTER CP ENDOSCOPIC CATHETER
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 61 KG