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

Catalog Number AWG2-35-450

Device Problems Positioning Failure (1158); Peeled/Delaminated (1454); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: cook glo-tip ercp catheter gt-1-t, cook cotton-leung sof-flex biliary stent clso-sf-10-9, coo tri-ex extraction balloon with multiple sizing txr-8.5-12-15-a.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.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 also 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat® 2 calibrated tip wire guide.The wire couldn't move at all.The nurse removed the wire and balloon simultaneously [lost wire guide access] and re-cannulated.After the wire was [in the duct], the stent followed the wire to insert it [the stent] into the duct but the stent could not move forward because of the resistance of the wire coating.Clarifying information was received noting the coating damage to the wire guide occurred at the patient end and less than 5 cm from the tip.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

Continued: section d: concomitant products: cook glo-tip ercp catheter gt-1-t, cook cotton-leung sof-flex biliary stent clso-sf-10-9, cook tri-ex extraction balloon with multiple sizing txr-8.5-12-15-a investigation evaluation: our evaluation of the product said to be involved could not confirm the report of wire guide coating damage.A visual evaluation of the product said to be involved could not confirm damage to the wire guide covering near the distal end of the wire guide.A small bend was observed at approximately 3.0 cm from the distal tip.No rough spots or fraying were observed anywhere on the device.For functional testing an extraction balloon with a 0.035" wire guide compatible lumen from our shelf stock was utilized.The device was flushed per the instructions for use (ifu) and tested in a coiled position to simulate a worst case scenario.The wire guide was observed exiting the distal tip, and no resistance was encountered during advancement.We were unable to recreate the difficulties experienced by the user.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: the root cause for the report of coating damage and unable to maintain wire guide position is unknown, because the device functioned as intended.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product 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.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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat® 2 calibrated tip wire guide.The wire couldn't move at all.The nurse removed the wire and balloon simultaneously [lost wire guide access] and re-cannulated.After the wire was [in the duct], the stent followed the wire to insert it [the stent] into the duct but the stent could not move forward because of the resistance of the wire coating.Clarifying information was received noting the coating damage to the wire guide occurred at the patient end and less than 5 cm from the tip.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® 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: 9662218
• MDR Text Key: 221332354
• Report Number: 1037905-2020-00059
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002476162
• UDI-Public: (01)10827002476162(17)220514(10)W4215221
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2020

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: 05/14/2022
• Device Catalogue Number: AWG2-35-450
• Device Lot Number: W4215221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJF 240 ENDOSCOPE.