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

Catalog Number FS-OMNI-ACRO-35-260

Device Problems Migration or Expulsion of Device (1395); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: (2) cook soehendra dilators, unknown models.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 subassembly device history record for the wire guide could not be reviewed because a lot number was not provided.The device history record for the lot number said to be involved could not be reviewed because a lot number was not provided.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 instruct the user to do the following: "for best results, wire guide should be kept wet." failure to flush the wire guide 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 fusion preloaded with acrobat wire guide sphincterotomes are subjected to a visual inspection to ensure device integrity.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

As reported to customer relations: a stent was in place from a previous endoscopic retrograde cholangiopancreatography (ercp).The fusion pre-loaded with acrobat wire guide sphincterotome was used to access the duct next to the existing stent.The wire guide was left in place in the duct and the sphincterotome was removed.A snare was passed through the endoscope and used to remove the stent.A soehendra dilator was passed over the in place acrobat wire and the common bile duct dilation was successful.The next size up soehendra dilator was passed over the acrobat wire.There was difficulty getting the dilator out of the endoscope channel.It was then noted that the acrobat wire coating had started to peel and was obstructing the dilator from passing over the wire.The dilator could not be advanced.The physician had to pull out both the wire guide and dilator from the duct and endoscope.A new acrobat wire guide had to be opened and used to gain access to the bile duct again [lost wire guide access].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.

• Brand Name: FUSION® PRE-LOADED WITH ACROBAT WIRE GUIDE
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): 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: 7685280
• MDR Text Key: 114541289
• Report Number: 1037905-2018-00312
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-OMNI-ACRO-35-260
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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