MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 5F SIM 1 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	451530H0
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354); Material Puncture/Hole (1504); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During prep for an unknown procedure, cracks/punctures/cuts were noted on the 5f tempo angiographic catheter on three points from the center of the catheter until the beginning of the sim shape in the distal part of the catheter.The catheter was broken in two or more pieces.There was a total break in the end of the catheter and two more breaks along the catheter.No patient injury was reported.The device was stored and handled per the instructions for use (ifu).The device was stored in the cath lab hanging out of the box for no more than two months.The integrity of the sterile pouch was not compromised.The device was inspected and prepped per the ifu, and the device did not prep normally.The breakage was noted during prep.The anomalies were noted while flushing the 5f tempo angiographic catheter, saline spilled from all the breakages.In a manual checkup of the catheter, the texture of the catheter is seen be fragile.The catheter was not used inside the patient.The procedure was completed successfully without patient injury.No other information was reported.The device was returned for analysis.A non-sterile unit of product cath tempo 5f sim 1 100cm was received for analysis coiled inside a plastic bag.Per visual inspection, a cracked and separated condition was noted on the catheter body.The separated condition is located at 91 cm from the hub.The cracks are located at 64, 65, 66, 69, 70, 73 and 76 cm from the hub.No other damages or anomalies were noticed.Functional analysis for the reported leakage was not performed due to the separation and cracks present on the catheter.Per dimensional analysis, the inner diameter (id) and outer diameter (od) of the body catheter was measured and were found within specification.Per microscopic analysis, a magnified image of the separation and the cracks was obtained.No elongations or stress material were noted.A dark residue of unknown material was noted inside of the catheter on the distal tip.Ftir results revealed that this material is blood.Ftir analysis confirmed that complaint samples and control samples analyzed share an overall similar infrared spectrum corresponding to a polyamide material (nylon), ruling out any change in the formulation of catheter used in the complaint unit.Although material degradation is observable on the comparison, this degradation seems to be localized close to the tip section and the cracking, since the appearance of the peaks in the complaint samples indicates the change in molecular structure caused by oxidation process that induces chain scissions closer to this section.The most common cause of degradation is light exposure also called photo-oxidation and it affects several synthetic polymers; ultraviolet lights interacts with free radicals to produce oxidation, this causes discoloration or yellowing and cracking.The dsc analysis of complaint samples shows similar melting points to control samples (around 176 ºc), and there is no evidence of any degradation or stress caused by heat.Granting there is a minor disparity in specific heat that could affected thermal performance and thermoplastic properties together with the ir spectra observed could represent an onset and localized photo-degradation.The reported ¿catheter (body/shaft) ¿ cracked during prep¿ and ¿catheter (body/shaft) ¿ separated during prep¿ were confirmed.Several cracks and a separated condition were noted on the body of the catheter.The exact cause of these damages could not be conclusively determined during the analysis, however storage and handling factors might have contributed to these issues.The reported ¿catheter (body/shaft) ¿ puncture/cut during prep¿ was not confirmed, however, several cracks were observed on the body of the catheter which could have been perceived as puncture/cuts.The reported ¿catheter (body/shaft) ¿ leakage during prep¿ could not be evaluated during analysis due to the separation and cracks present on the catheter.The exact cause of these damages could not be conclusively determined during the analysis.Dimensional analysis results were found within specification.Ftir analysis results confirmed presence of blood indicating that the catheter was clinically used and indicate that the most common cause of degradation is light exposure also called photo-oxidation and it affects several synthetic polymers.Storage factors might have contributed to this issue.Per the precautions in the instructions for use (ifu), which is not intended as a mitigation, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.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.Neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
As reported, there were cracks/punctures/cuts in the 5f tempo angiographic catheter three points from the center of the catheter until the beginning of the sim shape in the distal part of the catheter.The catheter was broken in two or more pieces.There was a total break in the end of the catheter and two more breaks along the catheter.No patient injury was reported.The device was stored and handled per the instructions for use (ifu).The device was stored in the cath lab hanging out of the box for no more than two months.The integrity of the sterile pouch was not compromised.The device was inspected and prepped per the ifu, and the device did not prep normally.The breakage was noted during prep.The anomalies were noted while flushing the 5f tempo angiographic catheter, saline spilled from all the breakages.In a manual checkup of the catheter, you can see the texture of the catheter is fragile.The catheter was not used inside the patient.The procedure was completed successfully without patient injury.The device will be returned for evaluation.

• Brand Name: CATH TEMPO 5F SIM 1 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8307316
• Report Number: 9616099-2019-02681
• Device Sequence Number: 1063874
• Product Code: DQO
• UDI-Device Identifier: 20705032008560
• UDI-Public: 20705032008560
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2019

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: 05/31/2020
• Device Catalogue Number: 451530H0
• Device Lot Number: 17680450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR