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

Catalog Number	MPIS-401-U-SST
Medical Device Problem Codes	Material Separation (1562); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a procedure a wire was being placed through an introducer into the patient.The wire "shredded" against the introducer needle and broke off inside the patient.At this time the patient required an open procedure to retrieve the wire.During this retrieval procedure, the wire was successfully removed from the patient.Additional information about the event and the device was requested but not provided.
Additional Manufacturer Narrative
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.One wire guide torq flex and needle were returned from a micropuncture transitionless access set.Wire guide was received separated.A kink is noted 1.3cm from proximal end.Weld ball is attached at distal end of coil.Coil is curved back on itself.One green hub needle was received.Lumen is obstructed with what appears to be biohazard material.The outer diameter of the wire measured out of specifications.However, the coil and the core were separated upon return and this separation could cause device measurements to be out of specification.In addition, the guide wire length measured out of specifications.However, the device was returned damaged and required stretching out the guide wire to measure the length which could account for the device measuring out of specifications.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.The customer stated that the wire shredded against the introducer needle then (the wire) broke off inside the patient.This device contains a warning label on the wire guide that shows a depiction warning not to pull the distal spring coil portion of the wire guide through the needle tip.Therefore, the user did not follow the instructions or labeling.Based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was technique-related.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• 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: 6446084
• Report Number: 1820334-2017-00519
• Device Sequence Number: 621791
• Product Code: DYB
• UDI-Device Identifier: 00827002479494
• UDI-Public: (01)00827002479494(17)191110(10)7434484
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 09/08/2017
• 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
• Patient Age: 81 YR