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

Catalog Number	MPIS-401-NT-SST
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = pre-amendment.Device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, the wire guide of the micropuncture transitionless access set was found to be kinked prior to patient use.Upon preliminary visual inspection by the manufacturer, the wire guide was unraveled.No patient adverse effects have been reported in relation to this event.
Additional Manufacturer Narrative
Additional information was received from the customer.It was reported that although the device was kinked only a little bit at first, when the operator attempted to use it, the coil of the wire unraveled.The device was also reportedly being used in a peripheral artery occlusive disease case, and slight calcification of the blood vessels was noted in the patient prior to treatment.The kinking of the device reportedly made insertion difficult.The operator ultimately changed to a new device to complete the procedure, and the outcome was reported to be successful.Investigation ¿ evaluation a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the mandril wire was exposed.The coil of the device was noted to be unraveled upon receipt; approximately 38 cm of wire was exiting the holder.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed one nonconforming event which could contribute to this failure mode; however, all affected units were either reworked or scrapped and not replaced.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, the root cause was traced to transport/storage of the device.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.This information is detailed in section h10.

• 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: 7906995
• Report Number: 1820334-2018-02648
• Device Sequence Number: 16596004
• Product Code: DYB
• UDI-Device Identifier: 00827002479425
• UDI-Public: (01)00827002479425(17)210501(10)8854937
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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 Expiration Date: 05/01/2021
• Device Catalogue Number: MPIS-401-NT-SST
• Device Lot Number: 8854937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1