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

Catalog Number	ACRO-35-450
Medical Device Problem Codes	Peeled/Delaminated (1454); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical product: cook tri-tome pc triple lumen sphincterotome, tri-25mp.Occupation: non-healthcare professional.Investigation evaluation: the photo provided by the user shows the wire guide coating coming off with bare core wire near the distal tip.The coating folded over itself distal to the bare core wire.A portion of wire guide coating was hanging off of the wire guide distal to the bare core wire.The coiled wire guide appeared to have a bend at the bare core wire.Our evaluation of the product said to be involved confirmed the report.There was wire guide coating damage near the distal end.At 11.8 cm to 12.9 cm from the distal end, the wire guide covering folded over itself.The frayed portion of wire guide covering was split down the middle and flattened at a couple locations.At 11.8 cm from the distal end, 11.7 cm of wire guide coating was hanging off.There was bare core wire from 12.9 cm to 25.6 cm.There were several bends from 232 cm to 256 cm.Most of the silver markings had a yellow tint.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.Coating damage contributes to the loss of wire access.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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat¿ calibrated tip wire guide.The user found out through endoscopy that the surface of the tip of wire guide peeled off [coating damage] during the procedure.The user withdrew the device [lost wire guide access] from the endoscope and patient and confirmed no surface was left in patient.The user used another [of the] same device to continue the procedure and finished.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
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8199812
• Report Number: 1037905-2018-00605
• Device Sequence Number: 137934
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)210719(10)W4092852
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2021
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4092852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS TJF-260V ENDOSCOPE
• Patient Age: 72 YR
• Patient Weight: 50