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

Catalog Number	MPIS-501-10.0-SC-NT-U-SST
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that during a tunneled catheter placement, the micropuncture transitionless stiffened cannula access set became caught on the needle during retraction and unraveled.All of the complaint device was able to be retrieved.The procedure was successfully completed using a new wire.The patient did not require additional intervention.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, documentation, drawing, quality control, specifications, and a visual inspection and functional evaluation of the returned devices were conducted during the investigation.The visual inspection of the returned device confirmed that the coil was elongated.The first attempt to pass the.018" wire through the 18s gauge was difficult, likely on account of the presence of biomatter.The wire was cleaned with isopropyl alcohol, and a second attempt to pass the entire length of the wire through the 18s gauge was successful and occurred without difficulty.From the proximal end, the wire remained intact for 33.5 cm before coil separation was seen at the solder junction.The coil was elongated 23.5 cm past the solder junction.The distal length of the wire after elongation was 3.7 cm.The overall length of the wire with the coil elongation was 60.7 cm.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, the device was 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, 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.

• 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: 7523064
• Report Number: 1820334-2018-00985
• Device Sequence Number: 13812712
• Product Code: DYB
• UDI-Device Identifier: 00827002480087
• UDI-Public: (01)00827002480087(17)210304(10)8640412
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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 Catalogue Number: MPIS-501-10.0-SC-NT-U-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1