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 11/13/2023

Event Type  malfunction  

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 detected that the coating of the wire guide peeled off during access establishment.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.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The guide wire was returned reinserted into the racetrack.There is wire guide coating damage near the distal end.A section of the coating has split exposing the core wire approximately 27.1cm to 28.5cm from the distal end.A shallow cut in the coating continuing from the peeled section was observed 28.5cm to 28.7 cm from the distal end, evidence of potential scoring damage contributing to the failure.No portion of the coating appears to be missing.A lab meeting was held with manufacturing engineering and photos were exchanged with production leadership on 12/07/2023.A visual inspection of the coating damage confirmed evidence of a scoring defect.This is the most likely cause for the coating damage.The device history record for the lot number said to be involved was reviewed.The same manufacturing nonconformances identified during the device evaluation was identified during the device history record review.Based on the review it is possible nonconforming product was released into distribution.A field action assessment was completed to determine if field action is required.In addition, production was notified in an effort to heighten their awareness.Investigation conclusion: our evaluation of the returned device confirmed the report.The coating at the distal end was damaged in manufacturing during the scoring process.This occurred due to operator error.Production management and the department team leads were notified of this occurrence.Additionally, a notification of operator related complaint form was provided to production management to make them aware of an operator related complaint.Retraining of the operator was completed to address this occurrence.A corrective action (capa) was initiated to investigate device failure related to coating damage cause by the scoring fixture.This device is within the scope of the capa.Prior to distribution, all acrobat¿ calibrated tip wire guides are subjected to a visual inspection to ensure device integrity.Corrective action: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product is included in the scope of this corrective action.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; 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: 18302439
• MDR Text Key: 330180278
• Report Number: 1037905-2023-00610
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002342665
• UDI-Public: (01)10827002342665(17)241216(10)W4547602
• Combination Product (y/n): N
• 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: 12/11/2023

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: W4547602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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 FS-OMNI SPHINCTEROTOME.; FUJINON-530XI ENDOSCOPE.
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 75 KG