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

Catalog Number	AWG2-25-450
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Use of Device Problem (1670); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: 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.According to the report, this 0.025" wire guide was used with a cook uts-20.The ultra taper sphincterotome is intended to be used with a 0.021" wire guide.Use with a non-compatible device can result in wire guide damage.Although the device was later used with a compatible device manufactured by another manufacturer, potential wire guide damage from use with the cook uts-20 could have contributed to the events described in this report.If additional or excess 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 2 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.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 2 calibrated tip wire guide.The physician gained access, had the wire in place and when he went to remove the cook ultra taper sphincterotome (uts-20), the wire would not stay in place.It all came back together and he lost access.(the wire was used with a cook non-compatible device.It was used with a (uts-20).The physician insisted on trying it and rep did not encourage the use of the device.) the uts-20 and wire stayed out.The physician then gained access with another manufacturer's [.035 device] and advanced wire through that and gained access without problem.He went to remove the balloon and keep wire access; however, the [other] wire came out again.They could not get the wire to stay in place and it gripped with the balloon.The wire was kept very wet and the racetrack was kept wet as well.

• Brand Name: ACROBAT® 2 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: 6678498
• Report Number: 1037905-2017-00435
• Device Sequence Number: 11256019
• Product Code: OCY
• UDI-Device Identifier: 00827002476103
• UDI-Public: (01)00827002476103(17)200403(10)W3839062
• Combination Product (Y/N): N
• PMA/510(K) Number: K142950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

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 Catalogue Number: AWG2-25-450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/06/2017
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1