MAUDE Adverse Event Report: WILSON-COOK MEDICAL, INC. HOWELL D.A.S.H. SPHINCTEROTOME

Model Number DASH-21-480

Device Problems Defective Component (2292); Folded (2630)

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

Event Date 10/27/2016

Event Type  malfunction  

Event Description

At the end of ercp case, during routine inspection prior to the pt leaving the operating room, a piece of the coating over the guide wire appeared to be missing.The operating room team nad neptune rep come and search the suction filter.No remnants of guide wire coating noted, x-ray performed with no signs of guide wire coating.Dr (b)(6) performed a thorough search with scope, nothing found.Pt transferred to the pacu and recovered as expected.The cook rep called, the guide wire is a cook product called howell d.A.S.H.Sphincterotome and he told (b)(6) that the sheath sometimes folds back onto itself after several passes over a prolonged period.(b)(6) looked under microscope and the sheath, coating over the guidewire, had in fact folded over itself and all pieces were accounted for.This is a defective product that has a tendency to fold over itself, appearing to be a retained foreign object, after prolonged use but there is no indication from the manufacturer as to how long is appropriate.If the sheath can bend back over itself, it can essentially break off causing a true rfo.

• Brand Name: HOWELL D.A.S.H. SPHINCTEROTOME
• Type of Device: HOWELL D.A.S.H. SPHINCTEROTOME
• Manufacturer (Section D): WILSON-COOK MEDICAL, INC.; 4900 bethania station rd; winston salem NC 27105
• MDR Report Key: 6068870
• MDR Text Key: 58833669
• Report Number: MW5065721
• Device Sequence Number: 1
• Product Code: KNS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DASH-21-480
• Device Lot Number: W3741591
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR