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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
It was reported that during a fistulogram of the left arm using a performer introducer, the sheath sheared off inside the patient's arm.Additional event details provided by the cook district manager was that "the attending physician stated that the fellow bent the sheath while it was inside of the patient which caused a piece of it to break off.The attending physician also stated that there was nothing wrong with the sheath, but rather the fellow made a mistake in handling the sheath.The sheath had to be snared thru the patient's groin.There was no unintended section of the device left inside of the patient.It was reported that there were no issues with the wire or any other instruments.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.One performer introducer sheath was returned for investigation.The sheath tubing was separated into two segments.The overall length of the two segments was found to be 6.2 cm.The tubing was jagged and slightly elongated at the separation sites.The distal separated segment was kinked in several locations.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Per the ifu: "this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths should be employed." "when inserting, manipulating or withdrawing a device through an introducer always maintain introducer position." based on the information provided and results of the investigation the root cause of this occurrence is most likely related to user technique.Per the quality engineering risk assessment, no further action is warranted.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: 6427673
• Report Number: 1820334-2017-00498
• Device Sequence Number: 16327488
• Product Code: DYB
• UDI-Device Identifier: 00827002134959
• UDI-Public: (01)00827002134959(17)191104(10)7418794
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RYCFW-6.0-35-6-CW
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: 04/10/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 07/13/2017
• 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: Required Intervention