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

Model Number N/A

Device Problems Fracture (1260); Material Separation (1562)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Reporter occupation: supply chain analyst.Device evaluation code desc: it is currently unknown if the device will be returned, but a return has been requested.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown procedure the catheter of a micropuncture transitionless access set broke.A portion of the device was not able to be removed during the procedure, thus the patient needed another procedure with ir to remove the fragment.Additional information has been requested and a follow-up report will be submitted when and if that information is received.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during an unknown procedure the catheter of a micropuncture transitionless access set broke.A portion of the device was not able to be removed during the procedure, thus the patient needed another procedure with ir to remove the fragment.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record, documentation, manufacturing instructions, and quality control data.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 made out of specification.A review of complaint history records shows no other complaints associated with the complaint device lot.A review of the device history record found two non-conformances potentially related to the reported failure mode.All affected product was scrapped.Because all potentially related nonconforming product was scrapped, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu) states that the complaint device is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21g needle stick is desired.The ifu also states, ¿when inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position,¿ and, ¿do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.¿ potential adverse events listed in the ifu include catheter embolism.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.With current information, a definitive cause for this failure could not be determined.It is possible that procedural factors or patient anatomy played a role in this failure.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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 Description

No new patient or event information to report.

• Brand Name: MICROPUNCTURE TRANSITIONLESS ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10563673
• MDR Text Key: 207912004
• Report Number: 1820334-2020-01719
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002479425
• UDI-Public: (01)00827002479425(17)230625(10)13269155
• Combination Product (y/n): N
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2023
• Device Model Number: N/A
• Device Catalogue Number: MPIS-401-NT-SST
• Device Lot Number: 13269155
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention