MAUDE Adverse Event Report: COOK ENDOSCOPY D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number DASH-ACRO-35-450

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 09/03/2015

Event Type  Injury  

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 subassembly device history record from the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.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: 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 report states: "in an effort to complete the procedure, a new d.A.S.H.® pre-loaded with acrobat wire guide sphincterotome was used and the same procedure performed.The same difficulties occurred, so device was pulled back again.Shortly before pulling it back into the endoscope, the user realized that the tip of the wire guide was torn off.The missing part of the tip was in the duodenum (not in the bile duct).According to the initial reporter, the physician attempted intervention in order to extract wire guide tip but was unsuccessful.The detached tip was left in the bowel so that it will pass by bowel movement and leave the body with stool." unfortunately, there is insufficient information to determine what portion of the wire guide tip detached.As a worst case, it is assumed that the coil spring assembly is what detached.The instructions advise the user that the wire guide should be kept wet for best results.The instructions for use describe the appropriate flushing techniques for use of this coated wire guide.These techniques described include, flushing the endoscope accessory channel and/or lumen of accessory device with sterile water before wire guide insertion.If these flushing techniques are not followed or inadequate flushing occurs, this can contribute to wire guide coating damage.Prior to distribution, all d.A.S.H.® pre-loaded with acrobat wire guide are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history records 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.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 subassembly device history record from the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.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: 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 report states: "in an effort to complete the procedure, a new d.A.S.H.® pre-loaded with acrobat wire guide sphincterotome was used and the same procedure performed.The same difficulties occurred, so device was pulled back again.Shortly before pulling it back into the endoscope, the user realized that the tip of the wire guide was torn off.The missing part of the tip was in the duodenum (not in the bile duct).According to the initial reporter, the physician attempted intervention in order to extract wire guide tip but was unsuccessful.The detached tip was left in the bowel so that it will pass by bowel movement and leave the body with stool." unfortunately, there is insufficient information to determine what portion of the wire guide tip detached.As a worst case, it is assumed that the coil spring assembly is what detached.The instructions advise the user that the wire guide should be kept wet for best results.The instructions for use describe the appropriate flushing techniques for use of this coated wire guide.These techniques described include, flushing the endoscope accessory channel and/or lumen of accessory device with sterile water before wire guide insertion.If these flushing techniques are not followed or inadequate flushing occurs, this can contribute to wire guide coating damage.Prior to distribution, all d.A.S.H.® pre-loaded with acrobat wire guide are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history records 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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook d.A.S.H.Pre-loaded with acrobat wire guide sphincterotome.They felt difficulty advancing the wire into the papilla, and upon removal noticed damage near the tip (see medwatch report 1037905-2015-00411).In an effort to complete the procedure, a new d.A.S.H.Pre-loaded with acrobat wire guide sphincterotome was used and the same procedure performed.The same difficulties occurred, so the device was pulled back again.Shortly before pulling it back into the endoscope, the user realized that the tip of the wire guide was torn off.The missing part of the tip was in the duodenum (not in the bile duct).According to the initial reporter, the physician attempted intervention in order to extract wire guide tip but was unsuccessful.The detached tip was left in the bowel so that it will pass by bowel movement and leave the body with stool.

• Brand Name: D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE
• 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: 5110385
• MDR Text Key: 26984089
• Report Number: 1037905-2015-00410
• 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: company representative,distri
• Reporter Occupation: Nurse

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DASH-ACRO-35-450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/03/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• 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: PENTAX ED 34-I10T DUODENOSCOPE