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 Patient Involvement (2645)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our evaluation of the product said to be involved did not confirmed the report of wire guide breakage.However, there is wire guide coating damage near the distal end.The coil spring is still attached to the distal end of the wire guide.The core wire was exposed from 24.0 to 27.0 cm distal from the tip with coating accordioned from 23.4 to 24.0 cm.The product also had a permanent distal bend starting at 12 cm distal from the tip.Several small kinks were found along the wire coating.Larger kinks were located at 202.5 cm and 245.5 cm distal from the tip, and the surface of the coating from 191 to 206 cm distal from the tip felt rough.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.The device history record for the lot number said to be involved was reviewed.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 product handling conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.The instruction for use instructs the user: "prior to removing wire guide from holder, flush with 30 cc of sterile water." this activity will aid in optimal performance of the wire guide.Failure to flush the wire guide can result in damage to the wire guide.Prior to distribution, all cook 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.

Event Description

In preparation for a procedure, the user selected a cook acrobat calibrated tip wire guide.The operator opened the package and found out the wire guide was broken.The body of wire guide was detached from the head [tip].During the device evaluation it was observed that the wire guide was not broken, but there was wire guide coating damage near the distal end of the wire guide.

• 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 Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7116839
• MDR Text Key: 95741666
• Report Number: 1037905-2017-00757
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)200914(10)W3916259
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2017

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2017
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• 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
• Patient Age: 60 YR
• Patient Weight: 56