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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Occupation: cath lab personnel.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 a percutaneous coronary intervention and diagnostic procedure, including an atherectomy of the right coronary artery, the wire included in a micropuncture transitionless stiffened cannula access set separated in the patient's left groin during access.The left femoral arterial access site was not reported to be scarred or calcified.The wire was removed through the entry needle after the wire separated.The separated portion of the wire, approximately 2 inches of the device, remains in the patient.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a percutaneous coronary intervention and diagnostic procedure, including an atherectomy of the right coronary artery, the wire included in a micropuncture transitionless stiffened cannula access set separated in the patient's left groin during access.The left femoral arterial access site was not reported to be scarred or calcified.The wire was removed through the entry needle after the wire separated.The separated portion of the wire, approximately 2 inches of the device, remains in the patient.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, and quality control data.One used device received.Biomaterial was present.Inspection found only 1.2cm of coil was left on the wire.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, 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.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: when inserting, manipulating or withdrawing a device through an introducer, always maintain introducer position.Do not attempt to insert or withdraw the wire guide and/or introducer if resistance is felt.Warning: do not pull the distal spring coil portion of the wire guide through the needle tip.A capa was previously opened in response to a ric which was submitted by capa to separate the failure mode of the outer catheter and wire guide of devices with "mpis" prefix.This capa will focus on the wire separation issue of the wire guides.The capa team determined the following root causes: the design and material choice of the stf and htf wire guides result in a lower tensile strength than the pmg wire guides which leads to a higher number of tip separation complaints seen in the field.The complaint analysis and returned devices, nc analysis, and the etl (engineering test lab) testing support this conclusion.The practice of removing the wire guide while the needle is still inserted in the blood vessel is known.This was supported by a complaint review and through discussion with product management.The capa was closed canceled at root cause on 17dec2018 as risk benefit analyses concluded the potential benefits of the device outweigh the risks identified.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.The investigation conclusion could not establish a possible cause.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 STIFFENED CANNULA ACCESS SET
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10680612
• MDR Text Key: 211442824
• Report Number: 1820334-2020-01858
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002480063
• UDI-Public: (01)00827002480063(17)230801(10)13342127
• Combination Product (y/n): N
• PMA/PMN Number: K171275
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MPIS-501-10.0-SC-SST
• Device Lot Number: 13342127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 92