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 Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: erbe electrosurgical generator.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.Three photos were provided and reviewed.An evaluation of the photos provided by the user confirmed the report.The catheter in the photos provided exhibits fraying and rippling confirming difficulty performing zip exchange resulting in lost wire guide access.Without return of the complaint device, a complete investigation could not be performed.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 corrective action has been initiated to reduce occurrences of stripping difficulty for fusion omni sphincterotomes.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all fusion omni-tome pre-loaded 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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of the this corrective action.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 two (2) cook fusion omni-tome pre-loaded sphincterotomes.The sphincterotome wire guide break-through channel was very hard to break, and created a long string of plastic coming from the sphincterotome.This caused the pulling of the wire guide out of the pancreatic duct and losing cannulation [lost wire guide access].The following additional information was received on 02/26/18: the wire-guide break-through channel was too difficult to peel-off, and a long string of plastic came from the sphincterotome.All this ended by losing the wire guide from the pancreatic duct [lost wire guide access] and extending the intervention (anesthesia, x-rays).

Manufacturer Narrative

Concomitant medical products: erbe electrosurgical generator.Investigation evaluation: an evaluation of the photos provided by the user confirmed the report.The catheter in the photos provided exhibits fraying and rippling confirming difficulty performing zip exchange resulting in lost wire guide access [subject of this report].Our evaluation of the product said to be involved confirmed the report of difficulty performing zip exchange resulting in lost wire guide access [subject of this report] and determined that the cutting wire securing component separated [see related mdr 1037905-2018-00148] the sphincterotome was returned, however, the wire guide associated with it was not included in the return.A visual examination of the returned sphincterotome showed that the entire breakthrough channel of the catheter was utilized.The drive wire broke at the center cannula and the anchor separated at the distal end of the catheter.Ripples were observed in the catheter of the returned device between approximately 39 cm - 43 cm showing stripping difficulty.Fraying was observed approximately 18.5 cm from the distal end.A kink was observed in the catheter approximately 147.5 cm from the distal end.The cutting wire showed signs of cautery application.The preloaded wire guide was not included in the return and therefore could not be evaluated.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The kink in the catheter, the anchor separation at the distal end of the catheter, and the breakage of the center cannula were likely caused by the difficulty the user experienced in pulling the wire guide through the breakthrough channel.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 corrective action has been initiated to reduce occurrences of stripping difficulty for fusion omni-tome sphincterotomes.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all fusion omni-tome pre-loaded 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: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of the this corrective action.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

The following was initially reporting to the fda on 03/20/2018: "during an endoscopic retrograde cholangiopancreatography (ercp), the physician used two (2) cook fusion omni-tome pre-loaded sphincterotomes.The sphincterotome wire guide break-through channel was very hard to break, and created a long string of plastic coming from the sphincterotome.This caused the pulling of the wire guide out of the pancreatic duct and losing cannulation [lost wire guide access].The following additional information was received on 02/26/2018: the wire-guide break-through channel was too difficult to peel-off, and a long string of plastic came from the sphincterotome.All this ended by losing the wire guide from the pancreatic duct [lost wire guide access] and extending the intervention (anesthesia, x-rays)." the device was evaluated on 03/20/2018 and it was observed that the cutting wire securing component had also separated [see related mdr 1037905-2018-00148].

• 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
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 7353361
• MDR Text Key: 103284672
• Report Number: 1037905-2018-00106
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002558144
• UDI-Public: (01)00827002558144(17)200805(10)W3901444
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K052051
• 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: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-OMNI-35-260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2017
• 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