MAUDE Adverse Event Report: COOK ENDOSCOPY DASH SPHINCTEROTOME; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number G25790

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2015

Event Type  malfunction  

Event Description

Using a dash sphincterotome, the wire became stuck somewhere near the catheter tip inside of the common bile duct.Alerted the md that it was difficult to pull back into the catheter and continued to try to work it free.It finally pulled free, but review of the fluoroscopy image showed that something was still in the duct.When we advanced the wire again, it pushed the item further into the duct.We were able to retrieve the item using a spybite forceps.Further inspection showed that the radiopaque coating had sheared off of the wire.The wire itself was still intact.

• Brand Name: DASH SPHINCTEROTOME
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd.; winston salem NC 27105
• MDR Report Key: 5044637
• MDR Text Key: 24664082
• Report Number: 5044637
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: G25790
• Device Lot Number: W3513304
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR