MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC D.A.S.H.® PRE-LOADED WITH ACROBAT WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number DASH-ACRO-35-260

Device Problem Peeled/Delaminated (1454)

Patient Problems Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

Event Description

During multiple endoscopic retrograde cholangiopancreatography (ercp) procedures, the physician used separate cook d.A.S.H.® pre-loaded with acrobat wire guides.It was reported that the wire guide breaks/peels during use.Despite rinsing with sterile water before each use, the wire sticks in the sphincterotome.The procedure takes longer, so the patient needs more medication.There is loss of access to the papilla, which increases the risk of pancreatitis.On several occasions there is permanent loss of access, so they are unable to complete the procedure.The patient needs to be re-examined at another time.Separate emdrs will be submitted to capture these events with different dates of events.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

Event Description

During multiple endoscopic retrograde cholangiopancreatography (ercp) procedures, the physician used separate cook d.A.S.H.® pre-loaded with acrobat wire guides.It was reported that the wire guide breaks/peels during use.Despite rinsing with sterile water before each use, the wire sticks in the sphincterotome.The procedure takes longer, so the patient needs more medication.There is loss of access to the papilla, which increases the risk of pancreatitis.On several occasions there is permanent loss of access, so they are unable to complete the procedure.The patient needs to be re-examined at another time.Separate emdrs will be submitted to capture these events with different dates of events.A section of the device did not remain inside the patient¿s body.It was reported that the papilla became inflamed which made access impossible and the procedure had to be done again at a later time.According to the initial reporter, the patient did not experience any other 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.A review of the device history record could not be conducted because the lot number was not provided.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.If additional pressure is applied to the wire guide and/or accessory device(s) while moving the wire guide inside the accessory device(s), this could contribute to wire guide coating damage.Prior to distribution, all d.A.S.H.® pre-loaded with acrobat wire guides are subjected to a visual inspection to ensure device integrity.Corrective action: 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.® PRE-LOADED WITH ACROBAT WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 17737125
• MDR Text Key: 323408952
• Report Number: 1037905-2023-00442
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DASH-ACRO-35-260
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ENDOSCOPE, UNKNOWN MAKE AND MODEL