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

Catalog Number	MPIS-402-10.0-SC-NT-U-SST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Pma/510(k) number = k133114.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 that the micropuncture transitionless stiffened cannula access set separated into two parts during an axillary bi-femoral bypass procedure.The sheath and dilator were inserted over the wire into the axillary access site.Reportedly, this site was neither significantly scarred nor calcified.The micropuncture wire and dilator were removed and a short benson wire was inserted.While the micropuncture transitionless stiffened cannula access set was being removed, it separated into two parts.The two parts were retrieved over the.035 guidewire sheath using forceps.A short sheath was put in place and an angioplasty was successfully completed resulting in a significant improvement in patency.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures and, according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the shaft was separated at a distance of 2.1 cm distal to the hub.The separated segment was measured to be 7.6 cm in length.The separated segment had a 20 degree bend that began approximately 3 cm from the point of separation.The inner dilator was received with the wire guide inserted in the dilator.The dilator exhibited a 15 degree bend that began approximately 9.5 cm from the proximal hub.The dilator was measured to be 11.4 cm in length.There was no additional damage noted to the dilator.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 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.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the 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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigational findings.

• 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: 7389346
• Report Number: 1820334-2018-00836
• Device Sequence Number: 10812188
• Product Code: DYB
• UDI-Device Identifier: 00827002355507
• UDI-Public: (01)00827002355507(17)210201(10)8555553
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/20/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MPIS-402-10.0-SC-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1