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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
(b)(4): the (b)(6) female patient was undergoing a balloon angioplasty procedure.The vascular sheath was inserted when leakage was noted.The sheath was changed out with no further incident.Per the report, a similar event happened previously in (b)(6) 2015 (referencing 1820334-2015-00876).No adverse consequence to the patient reported.
Additional Manufacturer Narrative
(b)(4).A review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection / functional testing of the returned device was conducted during the investigation.A performer introducer sheath was returned for investigation.Biomatter was present on the proximal fitting and within the connecting tube.Prior to performing a leak test, a cap to notch measurement was taken, the measurement of which has been determined may result in leakage.After flushing the device, a leak test was performed by occluding the sheath tubing with hemostats and injecting water through the connecting tube assembly using a cook inflation device.No leakage was detected.It is possible that there could have been biomatter still within the device, affecting the result of the leak test.Following the leak test, the proximal fitting was disassembled.Biomatter was found around the side of the silicone disc, between the silicone disc and valve body, and on the interior of the proximal fitting cap.Excessive glue was noted as well.The root cause for the leakage has been identified as inadequate tightening of the cap onto the valve body.It was found that valves with excessive glue on the cap threads and with glue between the flange of the valve body and silicone disc result in leakage.If the cap is inadequately tightened during manufacturing, glue can wick in between the flange and silicone disc.The presence of biomatter and glue between the silicone disc and valve body indicates that the cap had not been tightened sufficiently.While the failure of leakage could not be re-created, the findings are consistent with the aforementioned root cause.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
Per medsun report (b)(4): it was reported that the (b)(6) female patient was undergoing a balloon angioplasty procedure.The vascular sheath was inserted into an unspecified arm when leakage was noted.An unspecified device was being utilized through the sheath.A 0.035 wire was inserted into the lumen of the sheath prior to removal.The sheath was changed out with no further incident.The patient's anatomy was reportedly not tortuous nor calcified.No adverse consequence to the patient was reported.Per the report, a similar event happened previously in (b)(6) 2015 (referencing 1820334-2015-00876).

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6417181
• Report Number: 1820334-2017-00522
• Device Sequence Number: 16152337
• Product Code: DYB
• UDI-Device Identifier: 00827002106758
• UDI-Public: (01)00827002106758(17)191108(10)7425045
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2017

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: RYCFW-6.0-35-6-RB-CW
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2017
• Supplement Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1