MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number FS-OMNI-35-260

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: erbe electrosurgical generator; boston scientific rx locking device.Investigation evaluation: the product was returned for evaluation and the investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report with product evaluation information.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded sphincterotome.[it was] difficult to exchange the sphincterotome as the protective coating came off [of the] wire guide [coating damage].The sphincterotome was kinked during exchange as there was lots of resistance.Another sphincterotome and wire guide were used to cannulate [indicating loss of wire guide access].Clarification received on 24-aug-2018.The product was in a sealed bag.It [the coating damage] looked approximately 20-30 cm from the tip of the wire guide.The sales representative could not be 100 percent sure as the contaminated product was not taken out of the bag.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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded sphincterotome.[it was] difficult to exchange the sphincterotome as the protective coating came off wire guide [coating damage].The sphincterotome was kinked during exchange as there was lots of resistance.Another sphincterotome and wire guide were used to cannulate [indicating loss of wire guide access].Clarification received on 24-aug-2018.The product was in a sealed bag.It looked approximately 20-30 cm from the tip of the wire guide.I cannot be 100 percent sure as i have not taken the contaminated product out of bag.Additional clarification was received on 12-sep-2018.The information provided states that the user would have stripped down the sphincterotome using the orange stripping tool provided.The hole was created in the catheter to perform the exchange.They back loaded the sphincterotome and pushed the wire through the breakout channel near the metal band.The hole was created because they needed to go down with the sphincterotome again to extend the sphincterotomy.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

Erbe electrosurgical generator; boston scientific rx locking device.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The sphincterotome was returned with the associated wire guide lodged in the sphincterotome.A visual examination of area where the wire guide was stuck in the catheter showed a hole created next to the metal band on the catheter to perform an exchange.The catheter had been stripped backwards from the hole to approximately 11 cm from the distal end.The exchange was not done using the proximal skive for zipping the catheter, but was done using a hole created in the catheter near the metal band.The wire guide was recovered from the catheter and a visual examination was performed.Wire guide coating had frayed between 155.2 cm and 156.2 cm from the distal end.Bare core wire was exposed between 156.2 cm and 157.6 cm from the distal end and wire guide coating had bunched up between 157.7 cm and 159 cm from the distal end.Visual examination of the catheter showed kinks approximately 71.5 cm, 137 cm and 138 cm from the distal end.It is possible the interaction of the wire guide with the metal band resulted in wire guide damage.A functional test could not be performed due to the condition of the returned device.The sub assembly device history record for the wire guide said to be involved was reviewed.A discrepancy or anomaly was not observed.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: an evaluation of the returned product determined the root cause to be the hole created on the catheter next to the metal band to perform the exchange.Based on the responses to the additional questions asked to the user, a hole was intentionally created in the catheter to perform an exchange.This is against the instructions for use of the device.The instructions for use instruct the user "advance sphincterotome over pre-positioned wire guide ensuring that wire exits catheter at pwp" [proximal wire port].Interaction of the wire guide with the metal band is the most likely cause for wire guide damage.The instructions for use advise the user: "if preloaded, use of wire guide with metal tip ercp device may result in damage to external coating and/or tip of 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 omni-tome pre-loaded sphincterotomes 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: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered rare.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 OMNI-TOME PRE-LOADED SPHINCTEROTOME
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7856843
• MDR Text Key: 119657503
• Report Number: 1037905-2018-00398
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002558144
• UDI-Public: (01)00827002558144(17)210409(10)W4046223
• Combination Product (y/n): N
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2021
• Device Catalogue Number: FS-OMNI-35-260
• Device Lot Number: W4046223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJFT ERCP ENDOSCOPE