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

Catalog Number ACRO-35-450

Device Problem Peeled/Delaminated (1454)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.Investigation evaluation: a product evaluation was performed only by the pictures provided in response to this report, because the product said to be involved was not provided to cook for evaluation.Per the photos provided we cannot complete a full evaluation.The lot number provided in the photos matches this report.Our evaluation of the photos provided by the customer of the product said to be involved confirmed the report.There is wire guide coating damage near the distal end.The photos show damaged coating near the distal tip of the device, and the core wire is exposed.Without more markings visible at the distal end, it is difficult to estimate the specific location of the coating damage.It cannot be determined if any sections of the coating are missing based on the photos.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.The device history record for the lot number said to be involved was reviewed.The device history record contains nonconformances that could potentially be related to wire guide damage near the distal end.The device goes through various 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.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 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 Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook acrobat¿ calibrated tip wire guide.The physician detected the wire guide coating peeled off 5-20 centimeters (cm) from the tip while exchanging the balloon with the wire guide.The physician changed to another of the same device to complete 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.

Manufacturer Narrative

Initial reporter occupation: unknown.Investigation evaluation: the photos and our laboratory evaluation of the product said to be involved confirmed the report.There is wire guide coating damage near the distal end.A section of core wire was exposed from approximately 18.7cm to 26.9cm from the distal end.Due to the condition of the returned device it cannot be determined if any sections of the coating are missing.Approximately 6.2cm to 18.7cm from the distal end, the wire guide covering has folded over itself.For further evaluation, the coating was cut to observe the coating damage in more detail.It revealed that at approximately 18cm and from 18.4cm to 18.7cm from the distal end, the wire guide coating has folded over itself multiple times.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 lot number and sub assembly said to be involved were reviewed.The device history records contain nonconformances that could potentially be related to wire guide damage near the distal end.The device goes through various 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.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.

• Brand Name: ACROBAT 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: 11324182
• MDR Text Key: 259347869
• Report Number: 1037905-2021-00056
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002342665
• UDI-Public: (01)10827002342665(17)211023(10)W4135464
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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 Expiration Date: 10/23/2021
• Device Catalogue Number: ACRO-35-450
• Device Lot Number: W4135464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 03/12/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK EXTRACTION BALLOON, FS-8.5-12-15-A; COOK SPHINCTEROTOME, TRI-25M-P; OLYMPUS ENDOSCOPE, TF-260V
• Patient Age: 50 YR
• Patient Weight: 55