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

Model Number	G01253
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 035 quick cross, 035 cxi, (018,014 cxi) cook 18g cto, cook flexor high-flex ansel guiding sheath.Common name & product code: dqx wire, guide, catheter.Pma/510(k) number: pre-amendment.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 lower extremity angiogram via access in the right common femoral artery, a safe-t-j rosen catheter exchange wire guide separated.The target area was the superficial femoral artery.The anatomy was both tortuous and calcified.Resistance was reported on both insertion and removal of the device.The wire was not altered prior to use and no kinking was noted.The wire was being removed through a cook sheath at the time of separation.Wire access was lost and a femoral closure device could not be used.During the same procedure, a cook flexor high-flex ansel guiding sheath separated.That event will be reported under patient identifier (b)(6).A section of the device did not remain inside the patient¿s body.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.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during a lower extremity angiogram via access in the right common femoral artery, a safe-t-j rosen catheter exchange wire guide separated.The target area was the superficial femoral artery.The anatomy was both tortuous and calcified.Resistance was reported on both insertion and removal of the device.The wire was not altered prior to use and no kinking was noted.The wire was being removed through a cook sheath at the time of separation.Wire access was lost and a femoral closure device could not be used.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, quality control data, and specifications.The complainant returned thscf-35-260-1.5-rosen used to cook for investigation.Physical examination of the returned device showed: one wire and one sheath were returned used with bio present.The wire was separated at 77.6cm from the distal end of wire with no coil elongation.The wire appears to have been cut clean.The tnrt liner was on the wire along with sheath coils.The distal 8cm of the sheath was separated.With the proximal section measuring 46.7cm.Elongation of sheath material was present.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.This rpn is not shipped with any instructions for use (ifu).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 an adverse event related to patient condition contributed to this incident.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.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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: SAFE-T-J ROSEN CATHETER EXCHANGE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10733034
• Report Number: 1820334-2020-01933
• Device Sequence Number: 13664849
• Product Code: DQX
• UDI-Device Identifier: 00827002012530
• UDI-Public: (01)00827002012530(17)250824(10)13356832
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2025
• Device Model Number: G01253
• Device Catalogue Number: THSCF-35-260-1.5-ROSEN
• Device Lot Number: 13356832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 01/18/2021; 05/05/2021
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/21/2021; 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: KCFW-6.0-35-55-RB-HFANL0-HC.; KCFW-6.0-35-55-RB-HFANL0-HC