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 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter; occupation: unknown.The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

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 device exchange.The 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

Investigation evaluation: our evaluation of the product said to be involved confirmed the report.There is wire guide coating damage near the distal end.Approximately 17.4cm to 27.2cm from the distal end is a section of bare core wire.Approximately 8.0cm to 17.4cm from the distal end, the wire guide covering has folded over itself.Two sections of the folded over coating approximately 0.6cm long are frayed and hanging from the wire guide, and the coating is still attached approximately 8.0cm from the distal end.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A lab meeting was held with production personnel from wire guides on 12/22/21.Production management confirmed device was nonconforming due to coating damage caused during the scoring manufacturing process.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.Investigation conclusion: the coating at the distal end was damaged which was due to 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.Prior to distribution, all cook acrobat¿ calibrated tip wire guides are subjected to a visual inspection to ensure device integrity.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: 13026804
• MDR Text Key: 287415559
• Report Number: 1037905-2021-00707
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002342665
• UDI-Public: (01)10827002342665(17)240723(10)W4498566
• 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: 01/12/2022

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: W4498566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2021
• 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: OLYMPUS DUODENOSCOPE, MODEL UNKNOWN; OLYMPUS SPHINCTEROTOME, MODEL UNKNOWN
• Patient Age: 74 YR
• Patient Sex: Female