MAUDE Adverse Event Report: COOK ENDOSCOPY 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 10/09/2021

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 advanced the wire guide to bile duct and found out that the coating of the wire guide peeled off.Physician then changed to another of the same device to complete the procedure.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

Initial reporter; occupation: unknown.The product was received for evaluation and the investigation is on-going.A follow-up emdr report will be provided.

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 wire guide to bile duct and found out that the coating of the wire guide peeled off.Physician then changed to another of the same device to complete the procedure.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

Initial reporter; occupation: unknown.The product was received for evaluation and the investigation is on-going.A follow-up emdr report will be provided.

Manufacturer Narrative

Section e.Initial reporter; occupation: unknown.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.There is wire guide coating damage near the distal end.A section of core wire was exposed approximately 25.9cm to 27.7cm from the distal end.From approximately 25.3cm to 25.9cm area the coating has folded over itself multiple times.Due to the condition of the returned device it cannot be determined if any sections of the coating are 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.The device history record contains nonconformances that could potentially be related to coating damage.The device goes through various inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.A discrepancy or anomaly was not observed with the product that was released for distribution.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 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.

• 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: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12967579
• MDR Text Key: 286351188
• Report Number: 1037905-2021-00673
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002342665
• UDI-Public: (01)10827002342665(17)230616(10)W4355472
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

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 Expiration Date: 06/16/2023
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4355472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS JF-260V ENDOSCOPE
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 40 KG