MAUDE Adverse Event Report: COOK ENDOSCOPY ACROBAT 2 CALIBRATED TIP WIRE GUIDE; OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number AWG2-35-450-A

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook acrobat® 2 calibrated tip wire guide.A tear [coating damage] was found in the wire guide tip during use, but there have been no adverse effects to the patient reported.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.There is wire guide coating damage near the distal end.A section of core wire was exposed at approximately 5.5 cm from the distal end.Liquid was observed in the wire guide holder it returned loaded in.The wire guide is slightly bent at approximately 1.0 cm and 3.3 cm 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 with production supervision was held to evaluate the state of the returned device and condition of the distal tip.The review was unable to confirm a manufacturing defect associated with the manufacturing process at the distal end of the wire guide.Potentially due to the device handling, the core wire that was initially observed was no longer visible during the meeting with production management.Devices released for distribution go through multiple inspections to detect such defects.Inspections include visually verifying distal end of wire guide is smooth and free of sharp edges or points and inspecting product for kinks.Therefore, it is unknown how or at what point the coating at the distal tip became damaged.The device history record for the lot number said to be involved was reviewed.The device history record contains a nonconformance 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 cook acrobat 2 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 2 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
• MDR Report Key: 11100520
• MDR Text Key: 251101054
• Report Number: 1037905-2020-00581
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002476179
• UDI-Public: (01)10827002476179(17)230715(10)W4365162
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

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: 07/15/2023
• Device Catalogue Number: AWG2-35-450-A
• Device Lot Number: W4365162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, MAKE AND MODEL UNKNOWN; OLYMPUS ENDOSCOPE, JF260V