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

Catalog Number	ACRO-35-450
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook tri-tome pc triple lumen sphincterotome tri-25m, cook tri-ex extraction balloon tx-15-a.Investigation evaluation: our evaluation of the product said to be involved confirmed the report.A small 0.3 cm piece of wire guide coating was hanging off of the wire guide 9.7 cm from the distal end.At 9.7 cm 18.5 cm from the distal end, the wire guide coating had folded over onto itself at least once.There were a few slits in this folded over portion of coating.18.5 cm-26.9 cm from the distal end there is a section of bare core wire.There were some small kinks and rough surfaces felt throughout the length of the wire guide, most notably at the distal 2 cm and between 209 cm-219 cm from the distal end.A thin layer of unknown white substance has adhered to the wire guide throughout its length.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 nonconformance documented for the lot number said to be involved were reviewed, and were not found to be related to the complaint report.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.The instructions for use for this product line instruct the user: "prior to removing wire guide from holder, flush with 30 cc of sterile water." this activity will aid in optimal performance of the wire guide.Failure to flush the wire guide can result in damage to the wire guide.The instructions for use for this product line instruct the user: "flush endoscope accessory channel and/or lumen of device with sterile water, then insert wire guide floppy end first.Note: for best results, this wire guide should be kept wet, if applicable." this activity will aid in optimal performance of the wire guide.Failure to flush the endoscope channel can result in damage to the wire guide.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 calibrated tip wire guides are subjected to a visual inspection to ensure device integrity.A review of the nonconformance's documented for the lot number said to be involved was reviewed and confirmed that this lot met 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 covering [of the wire guide] peeled [and] detached from the wire guide.It was detected during the procedure.The device was evaluated on 04/12/2018 and it was observed that a small 0.3 cm piece of wire guide coating was hanging off of the wire guide, and the wire guide coating had folded over onto itself at least once.

• 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: 7469083
• Report Number: 1037905-2018-00167
• Device Sequence Number: 10791437
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)201030(10)W3989519
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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 Catalogue Number: ACRO-35-450
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2018
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1