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

Catalog Number	MPIS-401-U-SST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
The handle of the dilator ripped off while it was still in the patient.The rip occurred outside the patient.This made it very difficult to get the dilator that was inside the patient.The procedure was completed with the complaint device as they had already gained access before the difficulty occurred.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 Manufacturer Narrative
(b)(4).Investigation - evaluation.A review of the complaint history, device history record, documentation, specifications, quality control and visual inspection of the returned device was conducted during the investigation.Visual inspection of the returned product confirms fitting separation.Shaft material is still present within the hub.Therefore it is more probable this failure mode is contributed to material failure of the ptwt than the hub-shaft bond.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.Therefore it is more probable this failure mode is contributed to material failure of the ptwt than the hub-shaft bond.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
The handle of the dilator ripped off while it was still in the patient.The rip occurred outside the patient.This made it very difficult to get the dilator that was inside the patient.The procedure was completed with the complaint device as they had already gained access before the difficulty occurred.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.

• 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: 5790144
• Report Number: 1820334-2016-00608
• Device Sequence Number: 1503790
• Product Code: DYB
• UDI-Device Identifier: 00827002479494
• UDI-Public: (01)00827002479494(17)190422(10)6910912
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/14/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: MPIS-401-U-SST
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2016
• Supplement Report FDA Received Date: 01/03/2017
• 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