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

Model Number G47617

Device Problems Peeled/Delaminated (1454); Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

Continued from section d11: zeon medical xemex crusher catheter, lbgt7620s.Mtw by abis ercp catheter, unknown reference part number.Olympus visiglide2 wire guide, unknown reference part number.Investigation evaluation: photos were provided with this report.The evaluation of the photos provided show that the device is damaged distal to the 1 cm silver marking, making the distal end of the exposed core wire begin distal to 6 cm from the distal tip.The length of the exposed core wire cannot be measured by the photos but is estimated to be greater than 1 cm, making the proximal end of the exposed core wire begin distal to 5 cm from the distal tip.The coating has accordioned distal to the exposed core wire.Our evaluation of the product said to be involved confirmed the report.The tip of the returned device has two bends, one at approximately 1.3 cm from the distal tip and the other at approximately 5.2 cm from the distal tip.Approximately 3.8 cm to 4.4 cm from the distal end, the wire guide covering has accordioned.Approximately 4.4 cm to 5.8 cm and 6.9 cm to 7.2 cm from the distal end are sections of bare core wire.A section of the coating approximately 1.2 cm long is frayed and hanging from the wire guide, the coating still attached at approximately 7.1 cm from the distal end.The wire guide is bent approximately 13 cm to 24 cm and 224 cm to 226 cm from the distal end.Rough surfaces are found throughout the entire length of the wire guide.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.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 were 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 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.The instructions for use for this product line caution the user: "use of this wire guide with metal tip ercp devices may result in damage to the external coating and/or tip of the wire guide." it is possible that the device(s) used with this wire guide had a metal tip.Prior to distribution, all acrobat® 2 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

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat 2 calibrated tip wire guide.Cannulation was performed with the wire guide and another manufacturer's ercp catheter.The ercp catheter did not have a metal tip.The wire guide and another manufacturer's wire guide were used together to reach the desired branch of the intrahepatic bile duct.After advancing the wire guide in the desired branch, a different catheter from another manufacturer was advanced over the wire guide.During the advancement, the user felt strong resistance, because the lumen size around the porta hepatis was narrowed by stone(s) therefore, the user removed the wire guide from the body and he attempted to perform cannulation again but the user noticed on the endoscope monitor that the coating material of the wire guide was being peeled off [subject of this report], so he stopped using the wire guide.Another manufacturer's wire guide was used instead and the procedure was completed.There have been no adverse effects to the patient reported.The user noted that during the advancement of the second catheter over the wire guide, there was strong resistance.It may have caused friction between the wire guide and the metal part of the catheter and the wire guide got damaged.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 from section d11: zeon medical xemex crusher catheter, lbgt7620s.Mtw by abis ercp catheter, unknown reference part number.Olympus visiglide2 wire guide, unknown reference part number.Investigation evaluation: photos were provided with this report.The evaluation of the photos provided show that the device is damaged distal to the 1 cm silver marking, making the distal end of the exposed core wire begin distal to 6 cm from the distal tip.The length of the exposed core wire cannot be measured by the photos but is estimated to be greater than 1 cm, making the proximal end of the exposed core wire begin distal to 5 cm from the distal tip.The coating has accordioned distal to the exposed core wire.Our evaluation of the product said to be involved confirmed the report.The tip of the returned device has two bends, one at approximately 1.3 cm from the distal tip and the other at approximately 5.2 cm from the distal tip.Approximately 3.8 cm to 4.4 cm from the distal end, the wire guide covering has accordioned.Approximately 4.4 cm to 5.8 cm and 6.9 cm to 7.2 cm from the distal end are sections of bare core wire.A section of the coating approximately 1.2 cm long is frayed and hanging from the wire guide, the coating still attached at approximately 7.1 cm from the distal end.The wire guide is bent approximately 13 cm to 24 cm and 224 cm to 226 cm from the distal end.Rough surfaces are found throughout the entire length of the wire guide.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.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: the report states that this incident occurred while using this product with an metal tip device.This is the most likely cause for the reported observation.The instructions for use for this product line caution the user: "use of this wire guide with metal tip ercp devices may result in damage to the external coating and/or tip of the wire guide." prior to distribution, all acrobat® 2 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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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.Additional comments regarding this report: based on the information provided that the device was used off label with a metal tip device.A cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

The following was initially reported to the fda: "during an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat 2 calibrated tip wire guide.Cannulation was performed with the wire guide and another manufacturer's ercp catheter.The ercp catheter did not have a metal tip.The wire guide and another manufacturer's wire guide were used together to reach the desired branch of the intrahepatic bile duct.After advancing the wire guide in the desired branch, a different catheter from another manufacturer was advanced over the wire guide.During the advancement, the user felt strong resistance, because the lumen size around the porta hepatis was narrowed by stone(s) therefore, the user removed the wire guide from the body and he attempted to perform cannulation again but the user noticed on the endoscope monitor that the coating material of the wire guide was being peeled off [subject of this report], so he stopped using the wire guide.Another manufacturer's wire guide was used instead and the procedure was completed.There have been no adverse effects to the patient reported.The user noted that during the advancement of the second catheter over the wire guide, there was strong resistance.It may have caused friction between the wire guide and the metal part of the catheter and the wire guide got damaged." additional information was received on (b)(6) 2019 that indicated the wire guide was used with a metal tip 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® 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: 8828368
• MDR Text Key: 152403017
• Report Number: 1037905-2019-00414
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002476172
• UDI-Public: (01)00827002476172(17)220411(10)W4202511
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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: 04/11/2022
• Device Model Number: G47617
• Device Catalogue Number: AWG2-35-450-A
• Device Lot Number: W4202511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/25/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE, UNKNOWN MAKE AND MODEL
• Patient Age: 76 YR