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

Model Number	G10675
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
During a dialysis/fistulogram procedure, the physician gained access into the patient's left brachial vein with a micropuncture five (5) fr catheter from another manufacturer.This 5 fr micropuncture catheter was advanced, and both a left brachial and left subclavian angiogram were performed.Another manufacturer's glidewire angled (0.035 inches, 180 centimeters (cm)) was inserted.A cook medical manufactured check-flo performer introducer six (6) fr gauge was inserted into the left brachial vein and advanced, and the 5 fr micropuncture catheter was removed.The check-flo performer introducer reportedly had a defective valve which allowed blood loss from the dialysis fistula, and was replaced immediately following insertion.An over the wire (otw) balloon (not manufactured by cook medical) was inserted in the fistula.The otw balloon was inflated to 6 atmosphere (atm) for 120 seconds, a fistula angiogram was manually injected, and the otw balloon was removed.The procedure was able to be completed, and the physician stated that there were no patient complications.The patient lost approximately ten (10) milliliters (ml) of blood; no intervention was required as a result.During the procedure, the patient was given 5,000 units of heparin, and fourteen (14) milliliters(ml) of one (1) percent (%) xylocaine (lidocaine).The customer stated that d8 on the user facility (uf) medwatch report was incorrectly selected as "yes." the performer introducer was not reprocessed and reused on a patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.(b)(4).Investigation - evaluation.A review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.The sheath and the dilator of the performer introducer were returned in a used condition.Leakage was observed from the center of the silicone disc.No damage was observed on the silicone disc once disassembly of the check-flo was completed.After the sheath was tested for leakage, the check-flo assembly was separated from the connector cap for further examination and measurement.The check-flo cap was then disassembled from the check-flo body to examine the amount of glue.No excessive glue was present, it was present on the threads only.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record of the finished product shows no nonconforming events.A review of the raw material lots used to assemble the complaint device noted non-conformances; however, all non-conforming product was scrapped prior to processing of the final lot.It should be noted, 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; the root cause for the failure of leakage has been identified as inadequate tightening of the cap onto the valve body.Appropriate measures have been initiated to address this failure mode.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: 7039274
• Report Number: 1820334-2017-03682
• Device Sequence Number: 1239067
• Product Code: DYB
• UDI-Device Identifier: 00827002106758
• UDI-Public: (01)00827002106758(17)200511(10)7905146
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: G10675
• Device Catalogue Number: RYCFW-6.0-35-6-RB-CW
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 02/02/2018
• 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
• Patient Age: 57 YR