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

Catalog Number	ACRO-35-26010
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products.Cook fusion ide-tome (fs-25m-35).Investigation evaluation: our evaluation of the product said to be involved determined that there is wire guide coating damage near the distal end.The coil spring is still attached to the distal end of the wire guide.At 8.7 cm from the distal end, approximately 6 mm of the wire guide covering is hanging off of the wire guide.Approximately 8.7 cm to 9.2 cm from the distal end, the wire guide covering has folded over itself.Approximately 9.2 cm to 11.1 cm from the distal end is a section of bare core wire.Approximately 11.1 cm to 11.2 cm from the distal end, the wire guide covering bunched up like an accordion.The wire guide covering feels rough approximately 12.4 cm to 12.6 cm from the distal end.No further rough surfaces or kinks are found along the wire guide.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 returned device 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 to flush the wire guide prior to removal from the wire guide holder.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 to flush endoscope accessory channel and/or lumen of device with sterile water and for best results, wire guide should be kept wet.This activity will aid in optimal performance of the wire guide.Failure to flush the endoscope channel and/or lumen can result in damage to the wire guide.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
On (b)(6) 2016, we received the following information: during two (2) endoscopic retrograde cholangiopancreatography (ercp) procedures, the physician used a cook acrobat calibrated tip wire guide.The customer used a fusion idetome on both occasions.When the wire was locked into place then passed into the sphincterotome, and then passed down endoscope, the tip of the wire had slipped forward out of the sphincterotome.It was locked properly as checked by the senior nurse after nurse had set it up.Two cook reps also present to verify this.On 03/14/2016, one of the two devices was received for evaluation.There was coating damage present on the distal tip of the device.

• 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: 5562747
• Report Number: 1037905-2016-00075
• Device Sequence Number: 708378
• Product Code: OCY
• UDI-Device Identifier: 00827002442177
• UDI-Public: (01)00827002442177(17)181207(10)W3655344
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K142950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2016

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-35-26010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2016
• Initial Report FDA Received Date: 04/08/2016
• 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: OLYMPUS TJF260V ENDOSCOPE