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

Model Number	G02972
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non healthcare professional.Pma/510(k) number = pre-amendment.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, a female of unknown age with history of diabetes (type not specified), hypertension, and non-healing foot wound, was undergoing an unspecified peripheral intervention procedure utilizing a micropuncture transitionless pedal access set.Patient's anatomy was accessed via the calcified dorsalis pedis.During insertion of the introducer from the micropuncture transitionless pedal access set resistance was felt and reportedly, the device would only advance half-way.The purpose of the introducer placement was to facilitate placement of a larger guide wire.After the introducer was placed in the foot, the hub broke.There was no patient adverse effect.According to the complainant, a portion of the introducer did not remain in the patient's anatomy.No additional procedures were required.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation reviews of the device history record, complaint history, documentation, manufacturer¿s instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 shows no nonconforming events which could contribute to this failure mode.It should be noted that the only other complaint on this lot number is from the same facility on a similar procedure.This second complaint has been captured and submitted on 1820334-2019-00724.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.It should also be noted that there is no ifu for this device.Based on the information provided and no product returned, investigation has concluded that this event could not be traced to the device but to the patient¿s condition.Reportedly, the patient had heavy calcification and resistance was noted during the procedure.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

• 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: 8458731
• Report Number: 1820334-2019-00724
• Device Sequence Number: 16897417
• Product Code: DYB
• UDI-Device Identifier: 00827002029729
• UDI-Public: (01)00827002029729(17)190711(10)7108045
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/24/2019

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: 07/11/2019
• Device Model Number: G02972
• Device Catalogue Number: MPIS-401-PEDAL-NT-U-SST
• Device Lot Number: 7108045
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1