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

Catalog Number	ACRO-35-260
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product or photos of the product said to be involved were not provided to cook for evaluation.Only photos of the packaging were provided.Photos of the wire guide were not provided.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.The instructions for use advise the user that "for best results, wire guide should be kept wet." the instructions for use describe the appropriate flushing techniques for use of this coated wire guide.These techniques described include, flushing the endoscope accessory channel and/or lumen of accessory device with sterile water before wire guide insertion.If these flushing techniques are not followed or inadequate flushing occurs, this can contribute to wire guide coating damage.Prior to distribution, all acrobat calibrated tip wire guides are subjected to a visual inspection and functional test 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.On (b)(6) 2016, the packaging for a cook acro-35-260 device was received.The device itself was not received.There was no complaint reported from this facility for an acro-35-260 of the same lot number.After following up with the cook sales representative on the received device packaging, she reported the following on (b)(6) 2016: "i can't remember sending an acro-35-260 but it may be possible that there was one in the complaints bag which i could of forgotten about with a sphincterotome.The last complaints i sent from this facility were in two oversized orange biohazard bags (like bin bags) tied up.If this is the case, then the acrobat wire guide coating would of started stripping as this has happened a few times at this hospital.I will complete a product complaint form [for this device]." on 10/05/2016, we received the following information from the sales representative confirming that there was a complaint on the device: "staff inserted the acro-35-260 down the cook fusion omni-tome sphincterotome to see if the wire guide would enter the bile duct easier.While inserting the wire down into the sphincterotome, the wire started to bunch and could not be passed down the device [coating damage]." on 10/11/2016, we received confirmation from the sales rep that the damage to the wire guide occurred at 27 cm from the distal tip.

• 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: 6050544
• Report Number: 1037905-2016-00427
• Device Sequence Number: 54662
• Product Code: OCY
• UDI-Device Identifier: 00827002342651
• UDI-Public: (01)00827002342651(17)190607(10)W3731645
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K122816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/29/2016

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-35-260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2016
• Initial Report FDA Received Date: 10/24/2016
• 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: FUJINON DUODENOSCOPE, UNKNOWN MODEL