MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A performer introducer was being prepared to be used in a thorasic endovascular aneurysm repair.Upon opening the package, the physician observed the tip of the dilator to be damaged.A new device was used to complete the procedure.There was no patient involvement.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, specifications, quality control data, and visual inspection of the returned device was conducted during the investigation.One used performer introducer was returned in a prepped condition for investigation with liquid in the sidearm and the dilator fully inserted into the sheath.The dilator was removed from the sheath and reinserted without difficulty.No damage was noted to the sheath.Distal tip of dilator is bent and compressed.The compression is 1 mm in length measuring from the distal end.A review of the device history record did not present any indication of manufacturing defect or anomaly that could have impacted the event as reported.There is no evidence to suggest the product was not manufactured to current specifications or was damaged during the manufacturing process.The device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Though a definitive root cause could not be determined it is likely that the damaged tip was due to shipping/handling since device is inspected prior to shipment and the customer noted tip damage prior to patient contact.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6876395
• Report Number: 1820334-2017-03194
• Device Sequence Number: 11087084
• Product Code: DYB
• UDI-Device Identifier: 00827002116726
• UDI-Public: (01)00827002116726(17)200322(10)7674327
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 12/22/2017

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 Model Number: N/A
• Device Catalogue Number: RCFW-18.0P-38-30-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 60