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

Model Number	N/A
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	07/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a male patient underwent a femoral access procedure.During the procedure the wire began to uncoil when the dilator was introduced after the needle was removed.The patient was sent to the operating room to perform a cut down and retrieve the wire.No information has been provided regarding patient outcome.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, manufacturing instructions, specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.Two unused and unopened devices were provided and visually inspected.Examination of the supplied mandril guide confirmed that the devices were manufactured to specification.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.The device manufacturing record was reviewed and the lot met release criteria.There were no other reported complaints for this lot number.Based on the information provided 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.
Event or Problem Description
It was reported that a male patient underwent a femoral access / left heart cardiac catherization procedure.During the procedure the wire began to uncoil when the dilator was introduced after the needle was removed.The patient was sent to the operating room to perform a cut down and retrieve the wire.As stated in the user facility mdr # (b)(4) provided: micropuncture sheath was inserted into the right femoral.The wire was advanced and the dilator would not advance.The dilator was removed under fluoroscopy.The wire tip had gone down the artery instead of up.The physician attempted to remove the wire and felt resistance.Physician tried to put the dilator over the wire to remove the wire, but it could not be removed.The wire began to unravel; pressure held to site and a vascular surgeon was called.Vascular surgeon attempted to remove without success and patient was brought to the or to attempt removal.Wire was secured to the patient and patient transferred to surgery.Vascular surgeon assessed retained wire; additional wire adhered too deeply in the distal branch.It did not involve main deep femoral artery or superficial femoral artery (sfa).Due to wire in he muscular branch, a decision was made there would be more harm in dissection of distal muscular branch caused than leaving in place.A disclosure was made to the patient.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5875057
• Report Number: 1820334-2016-00777
• Device Sequence Number: 16255060
• Product Code: DYB
• UDI-Device Identifier: 00827002480094
• UDI-Public: (01)00827002480094(17)190602(10)7019041
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2016

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: N/A
• Device Catalogue Number: MPIS-501-10.0-SC-U-SST
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2016
• Supplement Report FDA Received Date: 01/06/2017
• 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: Required Intervention
• Patient Age: 68 YR