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

Model Number	N/A
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A micropuncture transitionless stiffened cannula access set was used in a right lower extremity angiogram.It was reported, when the physician tried to insert the wire through the "dilator," it would not advance and a "piece of metal" was noted to be sticking out of the hub of the alleged dilator.The physician was able to pull the metal out of the dilator and it appeared to be the stiffened part of the inner dilator.A section of the device did not remain inside the patient¿s body.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.Additional questions and product clarification have been requested.Upon receiving new information, a supplemental report will be submitted.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, manufacturing instructions, visual inspection, quality control, and review of drawing of the returned device was conducted during the investigation.The device history report reviewed showed one nonconformance for incorrect quantity.The dilator was reviewed and showed one nonconformance for in process contamination and the production work order was completed.Laboratory results showed a used micropuncture transitionless stiffened cannula access set was returned for examination.No damage was noted to the outer catheter.The dilator exhibited damage, including a compression at 5.7 cm from the proximal end which was 1.5 mm.Two wrinkles were also located at 9.9 cm and 10.2 cm from the proximal end.A 12.0 cm long metal cannula was also returned.3 bends were noted in the shaft at 4.0 cm, 7.0 cm, and 10.0 cm from the proximal end.3mm in length from the proximal end, discoloration is noted and the proximal is slightly flared.One used unidentified long metal cannula was returned.The length requirement did not meet specification.Also, the separated section was removed during the procedure, but not returned for evaluation.There is no evidence to suggest the product was not manufactured to current specifications or was damaged upon opening.It is feasible to conclude that patient anatomy could have contributed to the device complaint.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per risk assessment, no further action is required.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6806927
• Report Number: 1820334-2017-02613
• Device Sequence Number: 18866204
• Product Code: DYB
• UDI-Device Identifier: 00827002480070
• UDI-Public: (01)00827002480070(17)190615(10)7047406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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 Model Number: N/A
• Device Catalogue Number: MPIS-501-10.0-SC-NT-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1