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

Catalog Number	ACRO-25-450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: our evaluation of the product said to be involved confirmed the report.The core wire of the device separated at 7.2 cm with the wire guide covering surrounding the break fully intact.The wire guide covering at the core wire break is slightly bent, but is not otherwise stretched or deformed.The wire guide is kinked approximately 15.1 cm from the distal end.A rough surface was felt on the wire guide covering from approximately 30 cm to 35 cm.During evaluation, the wire guide covering was separated and the cross section was evaluated under magnification.Both ends of the broken core wire are slightly bent with no noticeable jagged edges.The diameter at both ends of the broken core wire were measured and confirmed to be the same (a bottle neck in the taper/grind was not found).A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.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.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: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered remote.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 a gastroscopy, the physician used a cook acrobat calibrated tip wire guide.The wire was broken into two (2) parts when withdrawn.The procedure was completed with another manufacturer's guidewire.

• 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: 7238021
• Report Number: 1037905-2018-00040
• Device Sequence Number: 16447414
• Product Code: OCY
• UDI-Device Identifier: 00827002327597
• UDI-Public: (01)00827002327597(17)200209(10)W3826990
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ACRO-25-450
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2018
• Device Age: 11 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 02/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 78