MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number DASH-35-480

Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 03/18/2014

Event Type  Injury  

Event Description

During an endoscopy procedure, a cook d.A.S.H.Dometip double lumen sphincterotome was used.During cannulation of the papilla to get into bile duct, the doctor accidentally cannulated the pancreatic duct with the metro wire of the dash-35-480.He pulled back the wire when he realized that it was the pancreatic duct and restarted cannulation of bile duct.After several attempts, the examiner changed and dr (b)(6) was able to get into the bile duct with the sphincterotome and wire.Contrast media was injected to make the bile duct visible under fluoroscopy.At that stage, dr (b)(6) saw that contrast was leaking out of the bile duct in the distal part [perforation].The pt was sent directly to surgery to close the leakage by surgical procedure.They also realized at that stage that there was a perforation in the pancreatic duct.A section of the device did not remain inside the patient's body.Other than surgery to repair the perforated sites, 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

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 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 conclusions: 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 state, "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." the instructions for use state, "potential adverse events associated with ercp include, but are not limited to perforation." prior to distribution, all d.A.S.H.Pre-loaded sphincterotome 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 remote.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: D.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; winston-salem NC 27105
• Manufacturer Contact: scottie fariole, mgr ; 4900 bethania station rd.; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 3940960
• MDR Text Key: 21999961
• Report Number: 1037905-2014-00227
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K901443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2017
• Device Catalogue Number: DASH-35-480
• Device Lot Number: W3385385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/18/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2014
• 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
• Treatment: OLYMPUS TJR-160 R ENDOSCOPE
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR