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

Catalog Number ACRO-35-450

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: cook zimmon pancreatic stent, spsof-5-6.Cook fusion pushing catheter, fs-pc-5.Cook fusion wire guide locking device, fs-wl-o-p.Boston scientific dreamtome rx44sphincterotome, unknown model.Boston scientific wallflex rx covered stent, 10 x 60 mm.Boston scientific needle knife, unknown model.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.A video was supplied by the customer, but no signs of wire guide coating damage could be discerned.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 instruction for use states: "use of this wire guide with metal tip ercp devices may result in damage to the external coating and/or tip of the wire guide." use of the wire guide with metal tip devices may compromise the integrity of the external coating on the wire guide.The reported observation can occur if the wire guide was used with an incompatible accessory device.The instruction for use instructs: "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 instruction for use instructs: "flush endoscope accessory channel and/or lumen of device with sterile water, then insert wire guide floppy end first.Note: for best results, 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.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 Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat calibrated tip wire guide.There was resistance with the acrobat wire guide during exchange over the sphincterotome and the user noticed the coating had stripped off.

Manufacturer Narrative

Concomitant medical products: cook zimmon pancreatic stent, spsof-5-6.Cook fusion pushing catheter, fs-pc-5.Cook fusion wire guide locking device, fs-wl-o-p.Boston scientific dreamtome rx44sphincterotome, unknown model.Boston scientific wallflex rx covered stent, 10 x 60 mm.Boston scientific needle knife, unknown model.Investigation evaluation: a product evaluation was not performed on the used device because the product said to be involved was not provided to cook for evaluation.A video was supplied by the customer, but no signs of wire guide coating damage could be discerned.The report could not be confirmed.An unused product was returned in a sealed pouch from the lot number provided in the report.The label matches the product returned.No rough surfaces or kinks were found along the wire guide during a visual inspection.The wire guide and the endoscope accessory channel were flushed with water prior to the functional test.The wire guide proceeded through the channel without resistance, and the sphincterotome was back loaded with the guide without meeting resistance.The sphincterotome was then loaded into the channel and forward loaded with the wire guide without meeting resistance.No damage was detected on the wire guide after the functional test.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: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.Only an unused product from the same lot number as the used device was provided with the return.A definitive cause for the reported observation could not be determined.The instructions for use states: "use of this wire guide with metal tip ercp devices may result in damage to the external coating and/or tip of the wire guide." use of the wire guide with metal tip devices may compromise the integrity of the external coating on the wire guide.The reported observation can occur if the wire guide was used with an incompatible accessory device.The instructions for use instructs: "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 instructs: "flush endoscope accessory channel and/or lumen of device with sterile water, then insert wire guide floppy end first.Note: for best results, 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.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.

• Brand Name: ACROBAT¿ 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
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7108484
• MDR Text Key: 95773414
• Report Number: 1037905-2017-00750
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)201004(10)W3923493
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: ACRO-35-450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/14/2017
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 12/18/2017
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1