MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET; DYB INTRODUCER, CATHETER

Catalog Number	MPIS-401-PEDAL-NT-U-SST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It has been reported that when using a micropuncture transitionless pedal access set device during a "peripheral intervention for superficial femoral artery (sfa)" the device separated.It was when the micropuncture sheath was being removed that the material separated.It was also reported that everything was removed from the patient without any complications or additional procedures.No unintended section of the device remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence, and no adverse events have been reported regarding the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, quality control, and a visual inspection of the returned device were conducted during the investigation.The returned device was an unopened, representative sample from the same lot as the complaint device.The complaint device was not returned.The visual inspection of the returned device confirmed that the surface of the outer sheath portion was free of imperfections.An examination and a tug test also confirmed that the outer sheath portion was secure in its fittings.The failure could not be duplicated.Additionally, a document based investigation evaluation was performed.A review of the device history record indicated that the lot met all finished goods release criteria.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned representative device, 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: MICROPUNCTURE TRANSITIONLESS PEDAL ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7155044
• Report Number: 1820334-2017-04578
• Device Sequence Number: 1951989
• Product Code: DYB
• UDI-Device Identifier: 00827002029729
• UDI-Public: (01)00827002029729(17)200825(10)8169294
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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 Catalogue Number: MPIS-401-PEDAL-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR