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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/10/2016
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 micro-puncture kit was used for accessing the right femoral artery under ultrasound guidance.It was further reported the needle punctured the artery and the wire was threaded into the artery.The wire was examined under flouro and revealed the wire had coiled upon itself and needed to be exchanged for a new wire.The physician had difficulty removing the wire and had to first remove the access needle.Upon removal of the wire, a visual inspection showed the wire frayed.Fluro revealed remnants of the wire in the patient anatomy.The access needle was visually inspected and reportedly ¿appeared appropriate." the attending physician consulted with two vascular surgeons and the determination was made to leave the fragments in the patients anatomy, the patient was informed of the decision.No additional information was available at the time of this report.
Additional Manufacturer Narrative
A review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection / functional testing of the returned device was conducted during the investigation.The supplied wire from the micropuncture transitionless access set was returned in a used and damaged condition.The distal coil was stretched out.The length of the wire under the coil was approximately 4 cm.The distal weld was missing.The core wire tip had a sheared appearance.The distal end of the coil was straightened, and the distal tip had a pinched appearance.The diameter dimensions of the mandril were within specification.The coil length was much longer than the specified 9 cm due to the coil being stretched.There is no evidence to suggest the finished product was not made to specifications.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.The device is shipped with an instruction for use (ifu) that is supplied with a cautionary label illustrating that the wire should not be pulled back through the needle.Additionally, the ifu states: "do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Withdrawal or manipulation of the distal spring coil portion of the mandril guide through a needle tip may result in breakage." and " caution: do not withdraw the wire guide through the introducer needle; breakage may results.If the wire guide tip must be withdrawn while the needle is inserted, remove both the needle and the wire as a unit." based on the information provided and results of the investigation the reported failure may be associated with the wire guide being damaged by withdrawal and/or manipulation through the needle.The most likely root cause may be related to user technique.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6150866
• Report Number: 1820334-2016-01358
• Device Sequence Number: 844206
• Product Code: DYB
• UDI-Device Identifier: 00827002438729
• UDI-Public: (01)00827002438729(17)190901(10)7244911
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MPIS-505-SST
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Supplement Report FDA Received Date: 06/08/2017
• 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: Other