MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE; KNS; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number FS-OMNI-ACRO-35-2015

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2015

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography(ercp), the physician used a cook fusion pre-loaded with acrobat wire guide sphincterotome.With multiple device exchanges, it was noted that mono-railing devices on pre-positioned wire in the cbd [common biliary duct] was becoming very difficult.Once the case was finished, it was seen that the hydrophilic end of the wire guide had started stripping.The customer advises that they had been seeing this occur quite frequently with short acrobat wires.An exact quantity was requested but was unable to be specified by the initial reporter.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.

Manufacturer Narrative

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.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 conclusions: 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 advise the user that the wire guide should be kept wet for best results.The instructions for use describe the appropriate flushing techniques for use of this coated wire guide.These techniques described include flushing the wire guide holder with 30 cc of sterile water prior to removing the wire guide from the holder, 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 detachment.If the endoscope or accessory device used with this device contains a sharp area or burr, this could contribute to wire guide coating damage.The instructions for use caution the user the elevator should remain open/down when advancing or retracting the sphincterotome.If the elevator of the endoscope is placed in the closed/up position with the sphincterotome inside the accessory channel, this could cause a kink in the sphincterotome and lead to wire guide advancement difficulty.Prior to distribution, all fusion pre-loaded with acrobat wire guide sphincterotomes 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.

• Brand Name: FUSION PRE-LOADED WITH ACROBAT WIRE GUIDE
• Type of Device: KNS; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 4704033
• MDR Text Key: 5718476
• Report Number: 1037905-2015-00147
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2017
• Device Catalogue Number: FS-OMNI-ACRO-35-2015
• Device Lot Number: W3508794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2014
• 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
• Treatment: COOK BILIARY DILATION BALLOON (UNK MODEL#); OLYMPUS DUODENOSCOPE (UNK MODEL #); COOK EXTRACTION BALLOON (UNK MODEL #); CONTROLLED RADIAL EXPANSION BALLOON