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

Model Number	G36333
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation = ir lab manager.Pma/510(k) number = pre-amendment.(b)(4).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
As reported, a (b)(6) year-old female patient weighing (b)(6) kilograms with a history of permanent dialysis catheter placement, underwent a procedure to place a tunneled dialysis catheter (tdc) via jugular access.It was during this procedure that a wire included in the micropuncture transitionless access set separated.The access site was not reported to be scarred or calcified, and resistance was not encountered during insertion or removal of the device.The wire guide was not manipulated or removed through a needle.The tip of the wire separated while the user was removing the 0.018 wire and inner dilator.The separated portion of the device was reportedly lodged in the tricuspid valve.The patient went into trigeminy (an abnormal heart rhythm), developed low blood pressure, and was not able to oxygenate.Anesthesia was called emergently, groin and internal jugular access were obtained, and the wire was retrieved with a snare.An emergent echocardiogram was obtained, and the patient was transferred to the intensive care unit for poor oxygenation.The tdc was reportedly placed.A section of the device did not remain inside the patient¿s body.
Additional Manufacturer Narrative
Investigation - evaluation reviews of the complaint history, device history record, documentation, drawing, manufacturer¿s instructions, quality control procedures, and specifications, and a visual inspection of the returned device were conducted during the investigation.On visual inspection of the returned device, the wire guide was broken at the solder point.The floppy tip of the wire was bent backward into a loop, and the wire was kinked approximately 2cm from the break site.The inner mandril was also kinked, approximately 1cm from the break site.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 multiple nonconforming events which could contribute to this failure mode.All of these were either inspected and found to be in conformance, however, or were scrapped and not replaced.It should be noted that there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, specifications, documentation, and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that no cause could 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 or Problem 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
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8666772
• Report Number: 1820334-2019-01352
• Device Sequence Number: 2268899
• Product Code: DYB
• UDI-Device Identifier: 00827002363335
• UDI-Public: (01)00827002363335(17)220306(10)9572786
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/27/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: G36333
• Device Catalogue Number: MPIS-501-SST
• Device Lot Number: 9572786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 74