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

Model Number	G10626
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a stentgraft placement, after the performer introducer was inserted into the patients anatomy, blood leaked from the valve of the hub.The procedure was able to be successfully completed utilizing another sheath.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, specifications, quality control, functional testing, dimensional verification, and visual inspection of the returned device was conducted during the investigation.One used performer introducer was returned for evaluation.The valve appeared to be damaged (a tear).Functional evaluation of the returned device showed a fine leak when room temperature water was injected into the check-flo valve.No other discrepancies were noted in the dimensional measurements made.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.However, the leakage could have been attributed to the tear observed on the valve, which could have occurred during insertion of the sheath over the wire guide.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.
Additional Manufacturer Narrative
Device evaluation begun, but is not yet complete.Per additional information received on 02nov2017, the performer introducer/ sheath was advanced into the patient's anatomy over a lunderquist extra-stiff wire guide using a dilator.When the physician attempted to removal of the dilator from the performer introducer/ sheath, blood began to leak from the valve.Investigation - evaluation: a preliminary review of the complaint history, device history record, documentation, specifications, and quality control was conducted during the investigation.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6988236
• Report Number: 1820334-2017-03737
• Device Sequence Number: 18863769
• Product Code: DYB
• UDI-Device Identifier: 00827002106260
• UDI-Public: (01)00827002106260(17)200526(10)7862815
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/22/2018

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: G10626
• Device Catalogue Number: RCFW-18.0P-38-40-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 11/02/2017; 02/28/2018
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 01/30/2018; 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1