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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The initial information received for this event did not report enough information to make a reporting determination.Several unsuccessful attempts were made to obtain additional information.The determination to report this event was made based on the investigation of the returned product completed on 21 jun 2016.Investigation ¿ evaluation: a review of complaint history, device record history, manufacturing instructions, dimensional verification, documentation, quality control, trends and visual inspection of the returned device was conducted during the investigation.The manufacturing record for this lot was reviewed, and nothing of note was observed.It should be noted that there are no other complaints of any nature associated with this lot.Review of device history record shows no nonconforming events which could contribute to this failure mode.The visual examination of the returned dilator reported 6mm of the distal tip had separated from the shaft, the separated segment was not returned.Damage point displayed no stress, elongation, or discoloration.The material was found to be soft and pliable with no discoloration of the packaging.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Multiple scenarios could have contributed to this event including: inappropriate heating during manufacturing/tipping or inadvertent damage during storage.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
During the procedure the clinician noticed the end of the dilator was damaged.The product was returned.Investigators determined that the tip had separated from the device on (b)(6) 2016.The event was made reportable on (b)(6) 2016.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5801983
• Report Number: 1820334-2016-00622
• Device Sequence Number: 1077242
• Product Code: DYB
• UDI-Device Identifier: 00827002270251
• UDI-Public: (01)00827002270251(17)171113(10)5387371
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RCFW-18.0P-38-85-RB
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2016
• Initial Report FDA Received Date: 07/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other