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

Catalog Number	MPIS-501-NT-U-SST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.[(b)(4)_hhs_fda_mw5081542_recvd 10dec2018_mnp.Pdf].
Event or Problem Description
An sus voluntary event report (mw5081542) was received 10dec2018.According to the report: during insertion of right subclavian swan placement, a micropuncture transitionless access set sheath and wire was inserted to place a central line.The tip of the micropuncture wire came off in the patient's body.The wire tip appears to be extravascular and not intravascular.No additional information was provided.Although requested, the initial reporter indicated no additional information will be provided.The complaint device is not available for return to the manufacturer to aid in the investigation.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, manufactures instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 revealed several nonconforming events which could contribute to this failure mode.However, all affected units were scrapped and not replaced prior to order completion.It should be noted there were no other reported complaints for this lot number.Additionally, there is no ifu for this device.However, there is a caution label on the wire guide holder that directs the user to not pull the wire guide through the needle once inserted, to avoid the needle damaging the wire guide.Furthermore, due to the rigorous quality control checking that takes place for all wire guides (every wire guide is checked, per our quality control instructions), and all nonconformant wire guides were scrapped and not replaced, there is no evidence to suggest that these nonconformances are related to the tip separation of the event.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.- attachment: [pr249056_hhs_fda_mw5081542_recvd 10dec2018_mnp.Pdf].
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8173977
• Report Number: 1820334-2018-03885
• Device Sequence Number: 2791989
• Product Code: DYB
• UDI-Device Identifier: 00827002438712
• UDI-Public: (01)00827002438712(17)210518(10)8895034
• 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: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2021
• Device Catalogue Number: MPIS-501-NT-U-SST
• Device Lot Number: 8895034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/29/2019
• 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: Other