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

Catalog Number ACRO-35-450

Device Problems Peeled/Delaminated (1454); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.Investigation evaluation: the photos provided show the wire guide inside of the damaged enbd catheter.The pouches/lot number in the photos match the report.Our laboratory evaluation of the product said to be involved determined wire guide coating damage.The wire was returned inside the enbd catheter and damage to the catheter was located at proximal end and at approximately 17.5 cm to 20.7 cm from the proximal end.The wire was removed from the device, with slight resistance experienced, and it was noted that the wire guide coating was damaged.The core wire was exposed from approximately 16.7 cm to 27.4 cm from the distal end.Approximately 8.6 cm to 16.7 cm from the distal end, the wire guide covering has folded over itself.No other anomalies were detected with the wire.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 wire guide damage near the distal end.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 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.Another possible contributing factor to wire guide damage is if the wire guide lumen is not flushed prior to wire guide advancement.The instructions for use also states, "flush endoscope accessory channel and/or lumen of device with sterile water, then insert wire guide floppy end first." 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

During an endoscopic procedure to place a drainage catheter, the physician used a cook acrobat¿ calibrated tip wire guide.The physician lubricated the drainage catheter first and then advanced it through [over] the wire guide, but felt obvious resistance during advancement and attempted to retract the drainage catheter from the wire guide.The physician could not retract the catheter from the wire guide after several attempts, and the drainage catheter kinked.The physician noted both drainage catheter and wire guide were stuck with each other and inseparable.The user retracted both the wire guide and drainage catheter together from patient [lost wire guide access] and changed another same device to complete the procedure.Additionally, damage to the coating of the wire guide was found at 16.7 cm from the distal end upon investigation of the returned device.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.

• 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: 10227339
• MDR Text Key: 212540141
• Report Number: 1037905-2020-00264
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002342665
• UDI-Public: (01)10827002342665(17)221106(10)W4283180
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/02/2020

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: 11/06/2022
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4283180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2019
• 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