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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
(b)(6) cook received user facility report number (b)(4): it was reported that while doing a sheath exchange during afib ablation / electrophysiologic study / pulmonary vein isolation / right heart catheterization / left heart catheterization / three-dimensional esi mapping, it was noticed that the tip of the performer introducer dilator had begun to fray.It was replaced with a new one and the case proceeded.At the end of the procedure when removing the sheaths, the new one had also frayed.Both were set aside and there was no harm to the patient.Both allegedly failed devices are from the same lot and shall be represented in this report.The patient's condition post-procedure was reportedly stable with minimal blood loss.The user facility reported that this has been a very successful ablation of atrial fibrillation and the patient was observed carefully overnight.
Additional Manufacturer Narrative
Cook received user facility report mfr# (b)(4).Investigation - evaluation: a review of complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications was conducted during the investigation.The complaint device was not returned, therefore no physical examination could be performed; however, document based investigation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Without the benefit of a returned complaint device, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.
Event or Problem Description
It was reported from the user facility that while exchanging a sheath during a procedure for atrial fibrillation ablation the medical team noticed the tip of the performer introducer dilator began to fray.It was replaced with a new one and the case proceeded.At the end of the procedure when removing the sheaths, the new one had also frayed.Both were set aside.There was no harm to the patient.The procedure was reported to be successful and the patient was last reported to be stable.Both complaint devices are from the same lot and shall be represented in this report.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6548022
• Report Number: 1820334-2017-00811
• Device Sequence Number: 13610025
• Product Code: DYB
• UDI-Device Identifier: 00827002080249
• UDI-Public: (01)00827002080249(17)191024(10)7231439
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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: RCF-14.0-38-J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2017
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR