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

Catalog Number AWG2-35-450

Device Problems Material Frayed (1262); Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

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 an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook acrobat® 2 calibrated tip wire guide.It was reported that the wire guide started to strip about 6cm away from tip.The physician started with an extraction balloon, the wire guide and a wire guide locking device.The physician went up the duct, did sweep and the wire guide fell out of duct.The physician pulled the wire guide back into the balloon fast and hard and the wire guide came out of the balloon.This happened twice.The third time feeding balloon and wire guide down, the physician noticed the wire guide was starting to strip [subject of this report].The physician got angry, ripped out the balloon and wire guide, and requested a boston scientific hydra wire guide & boston scientific 9-12 extraction balloon.The physician had issues cannulating with the boston scientific balloon but was eventually successful after five (5) minutes.Our attempts to collect additional information regarding patient outcome have been 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 an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook acrobat® 2 calibrated tip wire guide.It was reported that the wire guide started to strip about 6cm away from tip.The physician started with an extraction balloon, the wire guide and a wire guide locking device.The physician went up the duct, did sweep and the wire guide fell out of duct.The physician pulled the wire guide back into the balloon fast and hard and the wire guide came out of the balloon.This happened twice.The third time feeding balloon and wire guide down, the physician noticed the wire guide was starting to strip [subject of this report].The physician got angry, ripped out the balloon and wire guide, and requested a boston scientific hydra wire guide & boston scientific 9-12 extraction balloon.The physician had issues cannulating with the boston scientific balloon but was eventually successful after five (5) minutes.A section of the device did not remain inside the patient¿s body.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: the product said to be involved was returned in a white plastic bag.A lot number was not provided with the returned device.Our evaluation of the product said to be involved confirmed the report.The device had been reinserted into the racetrack which contained a clear liquid with the distal end visible.Coating damage was observed approximately 5.8 cm to 7.8 cm and 10.2 cm to 10.8 cm from the distal coating where it has split exposing the core wire.No portion of the coating is missing.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.A lab meeting was held on (b)(6) 2023 including production leadership, manufacturing engineering, and quality engineering to address if this product was nonconforming.Upon review of the product said to be involved it was determined that this product was conforming.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: our laboratory evaluation confirmed that the coating of the wire guide was damaged at the distal tip.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.However, the description of event states "got up duct, did sweep wire fell out of duct.Dr.Pulled wire back into balloon fast and hard, wire came out of balloon." which may have contributed to the damage observed.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): 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: 17060819
• MDR Text Key: 316705999
• Report Number: 1037905-2023-00273
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002476162
• UDI-Public: (01)10827002476162(17)260410(10)W4717268
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AWG2-35-450
• Device Lot Number: W4717268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2023
• 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: BOSTON SCIENTIFIC 9-12 EXTRACTION BALLOON; BOSTON SCIENTIFIC HYDRA JAGWIRE; COOK FS-8.5-12-15 EXTRACTION BALLOON; COOK SNAPLOC LOCKING DEVICE; OLYMPUS TJF-190 ENDOSCOPE
• Patient Age: 31 YR
• Patient Sex: Female