MAUDE Adverse Event Report: COOK ENDOSCOPY ACROBAT 2 CALIBRATED TIP WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number AWG2-35-205

Device Problem Peeled/Delaminated (1454)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

Continued: initial reporter; occupation: unknown.The investigation is on-going.A follow-up emdr will be provided within 30 days of submission of this report.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook acrobat® 2 calibrated tip wire guide and stated that the case had been quite difficult to start with due to the position of the papilla.A sphincterotomy was performed and they had good decompression of the duct.An extraction balloon was then placed over the wire but this [extraction balloon] was unable to advance up into the duct to perform an occlusion cholangiogram due to the stricture.At this point the senior consultant took over and advanced a dilation balloon up into the duct.This was then replaced by another manufacturer's fcsems [fully covered self-expanding metal stent] but they were unable to deploy this due to the stricture.At this point they decided to re-cannulate with another wire and deploy a cook evolution fcsems [stent] when the stent was loaded over the back of the wire it felt grainy to touch but nothing was thought of it.It was only when the stent had been pushed over the wire [that] it wouldn¿t advance, and they noticed that the coating had bunched up and was stopping the stent deploy.When they tried to pull the coating off to enable the stent to advance, this became impossible as it had bunched up, and whilst trying to pull the coating off, the wire was lost.They were then unable to re-cannulate as the patient was bleeding.The procedure was then abandoned, and the patient was transferred to the itu (intensive treatment unit).A section of the device did not remain inside the patient¿s body.The patient did require a follow up ercp due to this occurrence.According to the initial reporter, the patient did experience bleeding due to this occurrence and was transferred to the itu.

Manufacturer Narrative

Continued: section e.Initial reporter; occupation: unknown.The product was returned for evaluation on (b)(6) 2021 and the investigation is on-going.A follow up emdr report will be provided with the product evaluation information.

Manufacturer Narrative

Continued: section e.Initial reporter; occupation: unknown.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with damage to the wire coating approximately 170.3cm to 206.2cm from the distal tip.From the distal tip to approximately 3.0cm down the length of the wire guide, the wire guide is bent.A section of the coating approximately 1.1cm long is frayed and hanging from the wire guide, but the coating still attached at approximately 170.3cm from the distal end.An unknown red substance was observed near 170.3cm from the distal end.The device returned with a coiled and detached piece of wire guide coating measuring approximately 29.1cm when fully straightened.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.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: a definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.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 acrobat® 2 calibrated tip wire guides are subjected to a visual inspection and functional testing 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.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.

• Brand Name: ACROBAT 2 CALIBRATED TIP WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 11850480
• MDR Text Key: 251473354
• Report Number: 1037905-2021-00207
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002476124
• UDI-Public: (01)10827002476124(17)240224(10)W4441833
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2024
• Device Catalogue Number: AWG2-35-205
• Device Lot Number: W4441833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/19/2021
• Supplement Dates Manufacturer Received: 05/19/2021; 06/17/2021
• Supplement Dates FDA Received: 06/17/2021; 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AQUILLANT DUODENOSCOPE; COOK EVOLUTION BILIARY STENT SYSTEM-FULLY COVERED; DIAGMED FCSEMS STENT; EXTRACTION BALLOON, UNKNOWN MAKE OR MODEL; AQUILLANT DUODENOSCOPE; COOK EVOLUTION BILIARY STENT SYSTEM-FULLY COVERED; DIAGMED FCSEMS STENT; EXTRACTION BALLOON, UNKNOWN MAKE OR MODEL
• Patient Outcome(s): Required Intervention