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

Model Number G43869

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

Occupation = cphrm.Pma/510(k) number = k171275.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an atherectomy procedure involving a patient of unknown age and gender, a micropuncture transitionless access set wire unraveled and separated.This reportedly occurred while being passed through the needle upon initial placement of the device into the femoral artery; although, the physician was pulling back on the wire when the small portion detached.The device was used to facilitate placement of a larger diameter wire.The access site was described as normal and it is unknown if resistance was encountered.The detached portion, located just under the skin, was not retrieved and no intervention is currently planned.The procedure was completed successfully using another device of the same type.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, manufacturer¿s instructions, and quality control procedures 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 also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, quality control procedures, and the overall device history file were conducted, and no gaps were discovered.Based on the information provided and no product returned, investigation has concluded that a root cause for this event could not be established.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8713539
• MDR Text Key: 148464107
• Report Number: 1820334-2019-01482
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002438699
• UDI-Public: (01)00827002438699(17)220326(10)9622051
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: G43869
• Device Catalogue Number: MPIS-501-U-SST
• Device Lot Number: 9622051
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other