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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
The physician had an issue with a micropuncture transitionless access set where the wire got caught on the needle.The wire was stretched and unraveled but was able to be fully removed from the patient.There was some subcutaneous air in the area that made using the ultrasound difficult but there was no patient harm or additional procedures required.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The micropuncture transitionless access set was returned for evaluation.Visual inspection of the returned device revealed that the guide wire was unraveled at the distal end.The solder joint was noted to be intact.The unraveled section of the wire began approximately 5 millimeters (mm) from the solder point on the distal end and extended approximately 200 mm.The intact portions of the wire guide, including diameter, were within specifications.Visual inspection of the needle noted the presence of biomatter; otherwise, the needle was in good condition.A document based evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events on finished product which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Though no information was provided about whether the reported event occurred during insertion or removal of the guide wire; the design failure analysis indicates the failure most likely occurred during removal.The wire guide included is packaged with a pictograph attached to the holder that provides a warning against withdrawal of the wire guide through the entry needle.Based on the information provided and results of the investigation; however, a definitive root cause to the reported event could not conclusively be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6206364
• Report Number: 1820334-2016-01626
• Device Sequence Number: 873902
• Product Code: DYB
• UDI-Device Identifier: 00827002479500
• UDI-Public: (01)00827002479500(17)191021(10)7377912
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

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-405-SST
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 06/07/2017
• Patient Sequence Number: 1