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

Catalog Number	ACRO-35-450
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: cook triple lumen sphincterotome (tri-25m-p).Non-health care professional: investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Included in the return was 1 sealed device from the same lot.Complaint device - our evaluation of the product said to be involved confirmed the report.There was wire guide coating damage near the distal end.Wire guide coating peeled from one side of the core wire exposing bare core wire between 13.2 cm and 26.9 cm from the distal end.Wire guide coating remained intact on the other side of the core wire between 13.2 cm and 26.9 cm.A portion of frayed wire guide coating measuring approximately 14.7 cm in length was present at 13.2 cm from the distal end.No portion of the wire guide coating appeared to be missing.Sealed device - our evaluation of the sealed device could not confirm the report as it was described because the device functioned as intended.During functional testing, the wire guide lumen was flushed and advanced through a dash-acro-35-450 sphincterotome from our laboratory supply.The sphincterotome with pre-loaded wire guide was advanced inside an olympus tjf-160vf endoscope placed in a simulated biliary position.The distal end of the device was cannulated through the simulated papilla with the wire guide held in place using a wire guide locking device.A long wire exchange was performed where the sphincterotome was removed by pulling back on the catheter with the wire guide held in place.No resistance was encountered during this process.A visual examination of the wire guide showed no damage after completion of the long wire exchange.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history records for the wire guide sub assembly lot was reviewed.The wire guide subassembly device history record contained non-conformances that could potentially be related to wire guide damage.The device goes through different inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.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: 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 cook acrobat calibrated tip wire guides 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: 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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook acrobat calibrated tip wire guide.The device was advanced to the desired position, but the user felt obvious resistance during use.The user retracted the device from the patient and found out that the surface is partially peeled off from the wire guide [coating damage].The user checked and confirmed there was no surface [coating] of the wire guide left in the patient.The user changed to another of the same device to continue and finish the procedure.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.

• Brand Name: ACROBAT¿ CALIBRATED TIP WIRE GUIDE
• Common Device Name: OCY, ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8262551
• Report Number: 1037905-2019-00022
• Device Sequence Number: 19194630
• Product Code: OCY
• UDI-Device Identifier: 00827002342668
• UDI-Public: (01)00827002342668(17)211005(10)W4128326
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2021
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4128326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2018
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 65