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

Model Number	G47945
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation = non-healthcare professional.Pma/510(k) number = k171275.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
As reported, during a right radial arterial line placement procedure involving a (b)(6) male patient, the tip of the guide wire included in the micropuncture traditionless pediatric access set sheared off.Access was gained in the right radial artery, and the vessel appeared slightly calcified on ultrasound.However, resistance was not felt during insertion or removal.According to the initial reporter, the tip of the "catheter" (less than 1 cm) was retained in the subcutaneous tissue of the patient¿s skin, and because of the product¿s flexible end, removal was prevented.The complaint device was not manipulated or removed through the entry needle, and it was confirmed that the issue was experienced with the provided wire guide.The procedure was completed with the patient sedated and using ultrasound.According to the initial reporter, there is an image post procedure of the retained foreign body.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, and quality control procedures of the device were 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 shows eight nonconforming events for broken tip weld, all of which were identified and scrapped.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.A drawing is included with the complaint device warning the user against removing the wire through the needle.Reportedly, the device was not manipulated or removed through a needle in this case.Based on the information provided and no product returned, investigation has concluded that no cause could be established for the device failure.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.
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 PEDIATRIC ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8749890
• Report Number: 1820334-2019-01589
• Device Sequence Number: 2043504
• Product Code: DYB
• UDI-Device Identifier: 00827002479456
• UDI-Public: (01)00827002479456(17)220404(10)9644462
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

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 Model Number: G47945
• Device Catalogue Number: MPIS-401-PED-SST
• Device Lot Number: 9644462
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 09/09/2019
• 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; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 84