MAUDE Adverse Event Report: CORDIS CORPORATION CATH F4 INF 3DRC 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	538476
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17858865 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.
Event or Problem Description
As reported, a 4f 100cm right coronary 3-dimensional (3drc) infiniti diagnostic catheter was kinked with a hole during prep.It was noticed that the device was kinked after pre-loading the j-wire.A j-wire which is fresh out of package went through hole.Therefore, the procedure was completed using another unknown diagnostic catheter.There was no reported patient injury.The device was stored and handled as per the instruction for use (ifu).There was no damage noted to the packaging of the device prior to use.The device was prepped according to the ifu.The device was opened in the sterile field.The device will be returned for evaluation.Additional procedural details were requested but are unknown.
Additional Manufacturer Narrative
After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated accordingly.As reported, a 4f 100cm right coronary 3-dimensional (3drc) infiniti diagnostic catheter was kinked with a hole during prep.It was noticed that the device was kinked after pre-loading the j-wire.A j-wire which is fresh out of package went through hole.Therefore, the procedure was completed using another unknown diagnostic catheter.There was no reported patient injury.The device was stored and handled as per the instruction for use (ifu).There was no damage noted to the packaging of the device prior to use.The device was prepped according to the ifu.The device was opened in the sterile field.The device will be returned for evaluation.Additional procedural details were requested but are unknown.A non-sterile unit of an infiniti diagnostic catheter (cath f4 inf 3drc 100cm) was received for analysis coiled inside a plastic bag.Per visual analysis, three kinks were observed at 5.1cm, 24.2cm, and 46.4cm from the strain relief.No other anomalies were found.During functional analysis, a lab sample syringe filled with water was attached to the hub of the received catheter and successfully flushed.Neither obstruction nor resistance was observed during the flushing procedure.Also, no puncture was observed on the catheter body during the flushing procedure.The outer diameter (od) and inner diameter (id) of the unit were measured near every observed kink and the results were found within specification.A product history record (phr) review of lot 17858865 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) - puncture/cut¿ was not confirmed since no puncture or cut was observed on the catheter body during the flushing procedure.The reported event by the customer as ¿catheter (body/shaft) - kinked/bent - during prep¿ was confirmed since several kinks were observed on the catheter body as received.Nevertheless, dimensional results were found within specification.Procedural/handling factors may have contributed to the reported event.Per the instructions for use (ifu), although not intended as a mitigation, ¿exposure to temperatures above 54c (130f) may damage the catheter.To prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.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.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ neither the phr review nor the product analysis suggest that the observed damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH F4 INF 3DRC 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9438648
• Report Number: 9616099-2019-03390
• Device Sequence Number: 11371672
• Product Code: DQO
• UDI-Device Identifier: 20705032014929
• UDI-Public: 20705032014929
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K862244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: 03/31/2022
• Device Model Number: 538476
• Device Catalogue Number: 538476
• Device Lot Number: 17858865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 01/06/2020
• 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: UNKNOWN DIAGNOSTIC CATHETER
• Patient Age: 55 YR