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

Catalog Number	MPIS-501-SST
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that during a left and right heart study, the micropuncture transitionless access set broke leaving a portion of the device in the patient's anatomy.Radial access was not an option so a micropuncture transitionless access set was used to access the right jugular vein.During access the wire guide was placed in subcutaneous tissue.When the surgeon tried to remove it, it broke off at the point where the floppy tip begins.Approximately 5cm of wire guide was left in the subcutaneous tissue of the patient.The procedure was continued with a new micropuncture set which achieved venous access and then a 7fr sheath was inserted.A computed tomography (ct) scan was performed after the procedure to check placement of the wire guide within the patient and it was decided that retrieval was not necessary in this case.A section of the device did remain inside the patient¿s body.The patient did require an additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to for investigation findings.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Investigation evaluation: a review of the dimensional verification, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection and a functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the wire guide was damaged, and 5.7 cm of the wire guide were missing.Additionally, a document based investigation evaluation was performed.A review of the device history record showed the lot was released meeting all finished goods release criteria.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the 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.

• 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: 7523192
• Report Number: 1820334-2018-01428
• Device Sequence Number: 19298442
• Product Code: DYB
• UDI-Device Identifier: 00827002363335
• UDI-Public: (01)00827002363335(17)210125(10)8538073
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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 Catalogue Number: MPIS-501-SST
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 08/22/2018
• 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