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

Model Number	G28438
Medical Device Problem Codes	Difficult to Insert (1316); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2017
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 an abdominal aortic aneurysm (aaa) repair, the dilator was difficult to insert into the performer introducer sheath.The dilator was removed, re-flushed, and wiped down.The dilator was then able to be successfully re-inserted into the sheath; however there was resistance upon removal, and significant blood flow was encountered as the sheath check-flo valve came out with the dilator.The physician placed a finger over the sheath to restrict the patient's blood flow and exchanged the sheath with another one.It was noted that the blood loss with not significant.The sheath was placed in the patient's femoral artery during the procedure.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 dimensional verification, complaint history, device history record, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a kink in the sheath, which was approximately 22 cm distal from the distal end of the hub.No other damage to the sheath was noted.The silicone disc portion of the device was observed to be out of position; it was located in the distal end of the housing.Additionally, the slit on the silicone valve did not appear to cut across the entirety of the disc's diameter.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.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.Investigation evaluation: a review of the dimensional verification, complaint history, device history record, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a kink in the sheath, which was approximately 22 cm distal from the distal end of the hub.No other damage to the sheath was noted.The silicone disc portion of the device was observed to be out of position; it was located in the distal end of the housing.Additionally, the slit on the silicone valve did not appear to cut across the entirety of the disc's diameter.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.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: 7104536
• Report Number: 1820334-2017-04480
• Device Sequence Number: 13846621
• Product Code: DYB
• UDI-Device Identifier: 00827002284388
• UDI-Public: (01)00827002284388(17)200914(10)8188490
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: G28438
• Device Catalogue Number: RCFW-14.0-38-45-RB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1