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 Consequences Or Impact To Patient (2199)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.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 approximately 19.0 cm to 24.4 cm from the distal end.A section of the coating approximately 0.2 cm long is frayed and hanging from the wire guide, and the coating is still attached at approximately 18.9 cm from the distal end.Approximately 18.9 cm to 19.0 cm from the distal end, the wire guide covering has folded over itself.The wire guide has no kinks, but a few rough surfaces are found throughout the entire length of the wire guide.The condition of the returned device confirms that a section of wire guide coating is missing.This section was not returned for evaluation.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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 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 retrograde cholangiopancreatography (ercp) the physician used a cook acrobat¿ calibrated tip wire guide.The physician advanced the endoscope to the duodenal papilla and took the sphincterotome and wire guide to the common bile duct within 30 seconds.The physician flushed the sphincterotome's wire guide lumen as well as wire guide with saline before use and utilized a soaked gauze to wet the wire guide.There were three (3) stones after radiography, the biggest one around 10 mm diameter.The physician cut the duodenal papilla with the sphincterotome then used the a dilation balloon to complete the inflation.The physician advanced the wire guide through the wire guide lumen of the balloon the duodenal papilla but noted the balloon could not be advanced anymore.The physician retracted the balloon and wire guide from the patient and found out that the coating of the wire guide peeled off and piled up [subject of report] which caused the balloon device to not be advanced.Another wire guide was used 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.

• 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: 11156403
• MDR Text Key: 267742270
• Report Number: 1037905-2021-00016
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002342665
• UDI-Public: (01)10827002342665(17)230619(10)W4356787
• 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: 01/12/2021

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: 06/19/2023
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4356787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/21/2020
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2020
• 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: 46 YR
• Patient Weight: 72