MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6INF TL AR MOD 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	534648T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, while attempting to advance a 6f infinity tl ar mod 100cm diagnostic catheter, the 0.035 j wire kinked and when the catheter was pulled back into the radial artery, the distal tip of the catheter separated/broke approximately 4 inches from the distal end of the device.The patient was taken to the operating room and a cut down procedure was done.The patient was stated to be in good condition.The product was stored and handled according to the ifu.The product was inspected and prepped according to the ifu.The intended procedure was a left sided heart catheterization with a radial access site.There was no calcified lesion, or tortuosity.There was no vessel angulation, no stenosis or chronic total occlusion.The device was not re-sterilized.There was resistance met while advancing the device, and excessive torquing was required.Resistance was met while advancing the device over the guidewire.The device kinked in the area of separation.The device is being returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17943953 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3,h6 and h10.As reported, while attempting to advance a 6f infinity tl ar mod 100cm diagnostic catheter, the 0.035 j wire kinked and when the catheter was pulled back into the radial artery, the distal tip of the catheter separated/broke approximately 4 inches from the distal end of the device.The patient was taken to the operating room and a cut down procedure was done.The patient was stated to be in good condition.The product was stored and handled according to the ifu.The product was inspected and prepped according to the ifu.The intended procedure was a left sided heart catheterization with a radial access site.There was no calcified lesion, or tortuosity.There was no vessel angulation, no stenosis or chronic total occlusion.The device was not re-sterilized.There was resistance met while advancing the device, and excessive torquing was required.Resistance was met while advancing the device over the guidewire.The device kinked in the area of separation.One non-sterile unit of a cath f6inf tl ar mod 100cm diagnostic catheter was received for analysis.Per visual analysis, a material separation was observed on the body shaft of the unit at 89.8 cm from the strain relief.The separated area was observed elongated.Also, dried blood residues were observed on the separated distal portion of the unit.No other anomalies found.Per microscopic analysis, the separated infinity diagnostic catheter body shaft and the distal tip were inspected under the pal vision system.The edges on both separated areas presented a pattern that show evidence of material elongations, which are commonly associated with separations caused by material tensile overload.Also, diameter reduction was observed.Inner diameter (id) and outer diameter (od) measurements were taken near the damages and were found within specification.Functional analysis could not be performed.No sterile units were returned to perform functional pull test.A product history record (phr) review of lot 17943953 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿catheter (body/shaft)- separated - in-patient ¿was confirmed due to the separated condition of the returned unit.The exact cause of the separated condition could not be conclusively determined during the analysis.Procedural/handling factors may have contributed to the reported event.The product analysis results showed evidence of elongations.These findings suggest that the device was induced to stretching/pulling that exceeded the material yield strength prior to separation.Per the instructions for use (ifu), although not intended as a mitigation of risk, ¿exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ neither the product analysis results nor the phr review suggest that this event is related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: CATH F6INF TL AR MOD 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13060127
• Report Number: 9616099-2021-05219
• Device Sequence Number: 1609088
• Product Code: DQO
• UDI-Device Identifier: 10705032014366
• UDI-Public: (01)10705032014366(17)230331(10)17943953
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

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 Expiration Date: 03/31/2023
• Device Model Number: 534648T
• Device Catalogue Number: 534648T
• Device Lot Number: 17943953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.035 J WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male