MAUDE Adverse Event Report: COOK INC SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number G01253

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

Name and address: postal code: (b)(6).Pma/510k #: k171764.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 retrograde phlebography and using a safe-t-j rosen catheter exchange wire guide, the wire guide was releasing ptfe fibers.The procedure was completed using another guide wire.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Additional patient and event information has been requested.

Event Description

Additional info was received on 13jul2021: the access site was the superficial femoral.Moderate calcification of the patient's anatomy was noted.Angioplasty of the iliac, heparin, and contrast were all used during the procedure.A cook medical introducer and catheter of unspecified product number were also used.There was no kinking of the wire.The fibers were not released into the patient.

Manufacturer Narrative

The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a retrograde phlebography and using a safe-t-j rosen catheter exchange wire guide, the wire guide was releasing ptfe fibers.The access site was the superficial femoral.Moderate calcification of the patient's anatomy was noted.Angioplasty of the iliac, heparin, and contrast were all used during the procedure.A cook medical introducer and catheter of unspecified product number were also used.There was no kinking of the wire.The fibers were not released into the patient.The procedure was completed using another guide wire.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record, the instructions for use, 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 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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings ¿this product is a delicate instrument.Avoid forceful angulation.¿ ¿avoid manipulating or withdrawing the wire guide back through a metal needle or cannula.A sharp edge may scrape or shear material from the wire guide.¿ precautions ¿do not attempt to torque the wire guide.¿ ¿using medical imaging when you manipulate the wire guide.Do not advance or manipulate the wire guide without visual evidence of the corresponding movement of the distal tip.¿ ¿do not advance or withdraw a wire guide when resistance is encountered as a perforation could occur.¿ ¿inspect the wire guide for kinks or damage prior to use.¿ how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ 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.Cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.It is possible the moderate calcification of the patient anatomy contributed to the 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.

• Brand Name: SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 12103580
• MDR Text Key: 263559075
• Report Number: 1820334-2021-01662
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002012530
• UDI-Public: (01)00827002012530(17)240828(10)9947954
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/12/2021

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?: Yes
• Device Model Number: G01253
• Device Catalogue Number: THSCF-35-260-1.5-ROSEN
• Device Lot Number: 9947954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/01/2021
• Supplement Dates Manufacturer Received: 07/13/2021; 10/26/2021
• Supplement Dates FDA Received: 07/19/2021; 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female