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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported a micro-puncture wire sheared off in the patient.Resistance was reportedly encountered during the removal process and the wire was noted to have kinking.The sheared wire was retrieved and no additional procedures were necessary.Additional information has been requested but not provided at the time of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, manufacturing instructions, quality control, specifications, trends, and visual inspection of the returned device was conducted during the investigation.The torq-flex tm wire guide was the only component of the micropuncture transitionless access set returned for evaluation.The wire guide was visually examined.It was severely elongated and solder was not present at the distal connection.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.

• 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: 6236687
• Report Number: 1820334-2017-00046
• Device Sequence Number: 440167
• Product Code: DYB
• UDI-Device Identifier: 00827002477087
• UDI-Public: (01)00827002477087(17)191025(10)7385953
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MPIS-505-U-SST
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 05/24/2017
• 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