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

Model Number G34266

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Reporter occupation: non-healthcare professional.Investigation evaluation: a photo was provided in response to this report.The photo depicts the distal end of the device, which shows bare core wire between the 20 cm band markings and the 25 cm band markings.A piece of coating has separated from the core wire but remains connected to the device at either end of the wire guide damage.There is a significant bend in the wire guide where the damage occurred.Our evaluation of the product said to be involved confirmed the report.The wire guide was noted to have been loaded backwards into the wire guide holder upon receipt.Approximately 22.2 cm to 24.2 cm from the distal end is a section of bare core wire.A section of the coating approximately 2.0 cm long is frayed and hanging from the wire guide, the coating still attached at approximately 22.2 cm and 24.2 cm from the distal end.Approximately 20.7 cm to 20.9 cm from the distal end, the wire guide covering has accordioned.Approximately 24.5 cm to 25.2 cm from the distal end, the wire guide coating appears worn.The wire guide is kinked approximately 3 cm from the distal end as well as 18 cm to 26 cm from the distal end.Rough surfaces are found throughout the entire length of the wire guide.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history records for the wire guide lot was reviewed.The wire guide device history record contains nonconformances that could potentially be related to wire guide damage.The device goes through different 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 prior to use preparation conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all acrobat® calibrated tip wire guides are subjected to a visual inspection and functional testing 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

Prior to a endoscopic procedure, the physician opened a cook acrobat¿ calibrated tip wire guide from the packaging.It was found out that the coating of the wire guide peeled off.The physician changed to another cook acrobat¿ calibrated tip wire guide to complete the procedure.Based on the photo provided, the damage appears to be around 20-25 centimeters (cm) this occurred prior to patient contact; there was no impact to the patient.

• 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: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 9341674
• MDR Text Key: 219165809
• Report Number: 1037905-2019-00708
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)220516(10)W4216273
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

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: 05/16/2022
• Device Model Number: G34266
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4216273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 10/25/2019
• Initial Date FDA Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2019
• 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