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

Catalog Number AWG2-35-260

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.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.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 covering of the wire guide peeled off when retrieving the sphincterotome.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects, or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

Event Description

The following was reported on (b)(6) 2020: ¿during an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat® 2 calibrated tip wire guide.The covering of the wire guide peeled off when retrieving the sphincterotome.¿ the subject of this report was coating damage to the wire guide.New information was received on (b)(6) 2020: ¿there was peeling of plastic [coating] of the wire guide during insertion of the guide-wire the after peeling the catheter [zip exchange].The user removed sphincterotome and the guidewire [lost wire guide access, subject of this report] and changed with same devices [sic].¿.Photos also provided on (b)(6) 2020 indicate that the damage to the wire guide coating is at a location where there are no markings on the device.Therefore, the damage occurred at the user end.Coating damage in this location does not meet the requirement for fda reporting.Therefore, coating damage is no longer the subject of this report.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

Investigation evaluation: a product evaluation was performed only by the pictures provided with this report because the product said to be involved was not provided to cook for evaluation.A photo of the lot number was not provided.Our photo evaluation of the product said to be involved confirmed the report.The pictures provided show coating damage on an unknown location of the device.The core wire is exposed and the wire guide covering is partially detached from the wire guide.No markings on the device are visible preventing estimation of the location or length of the damage.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: 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 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.

Manufacturer Narrative

Investigation evaluation: the pictures provided show coating damage on an unknown location of the device.The core wire is exposed and the wire guide covering is partially detached from the wire guide.No markings on the device are visible preventing estimation of the location or length of the damage.Our laboratory and photo 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 56.6 cm to 74.5 cm from the distal end.A section of the coating approximately 1.8 cm long is frayed and hanging from the wire guide, the coating still attached at approximately 56.6 cm from the distal end.Another section of the coating approximately 16.7cm long is frayed and hanging from the wire guide, the coating still attached at approximately 74.5 cm from the distal end.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 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.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.

• 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: 10521492
• MDR Text Key: 216419487
• Report Number: 1037905-2020-00367
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002476148
• UDI-Public: (01)10827002476148(17)230402(10)W4337180
• 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,Followup
• Report Date: 12/02/2020

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: 04/02/2023
• Device Catalogue Number: AWG2-35-260
• Device Lot Number: W4337180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/18/2020; 11/10/2020
• Supplement Dates FDA Received: 10/14/2020; 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK FS-OMNI, SPHINCTEROTOME.; COOK FUSION SPHINCTEROTOME, UNKNOWN RPN.; ENDOSCOPE, MAKE AND MODEL UNKNOWN.; OLYMPUS TJF 145, ENDOSCOPE.
• Patient Age: 73 YR