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

Model Number	G08956
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that during an endovascular aneurysm repair (evar) in the aorta, after introducing all the evar components, the introducer was switched for a 12 fr performer introducer.The performer introducer was observed to be heavily leaking blood from the valve and hemostasis was unable to be maintained, even when a 0.035 inch diameter wire guide and catheters (reporter specified that another manufacturer's 5 fr catheter was used) were passed through the valve.Due to the leakage, the procedure was required to be performed quickly, but was able to be successfully completed.No intervention was required.Everything was placed in the center of the introducer and the membrane was not punctured.Access was gained through the right leg via a contralateral approach.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.It was noted that similar events with leakage have occurred previously with other 12 fr performer introducers (refer to medwatch 1820334-2018-00540) and a 14 fr performer introducer (refer to medwatch 1820334-2018-00394).Per the initial reporter, no additional information is available.
Additional Manufacturer Narrative
Describe event or problem narrative: it was later clarified by the customer in a response to a request for additional information that no similar leakage events occurred previously with other 12 fr performer introducers (refer to medwatch 1820334-2018-00540).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a wrinkle in the sheath tubing 1.8 cm from the distal tip.A leak test was then performed by occluding the sheath tubing with hemostats, and then injecting water through the side-arm using a 20cc syringe.Leakage was observed from the center of the silicone disc.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed two nonconforming events which could contribute to this failure mode; however, all nonconforming product was scrapped, replaced, and inspected for leakage prior to release.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7280708
• Report Number: 1820334-2018-00393
• Device Sequence Number: 16382896
• Product Code: DYB
• UDI-Device Identifier: 00827002089563
• UDI-Public: (01)00827002089563(17)201129(10)8345868
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2018

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: G08956
• Device Catalogue Number: RCFW-12.0-38-30-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 03/01/2018; 04/02/2018
• Initial Report FDA Received Date: 02/19/2018
• Supplement Report FDA Received Date: 03/02/2018; 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1