MAUDE Adverse Event Report: CATH F6INF TL JR 4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	534621T
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
When opening the pouch and preparing the 6f 100cm judkins right (jr4) infiniti diagnostic catheter, the sterile nurse identified a small hole approx.15cm distal of the tip.Therefore, a new catheter (unknown) was opened and used for the patient.There was no reported patient injury.A new diagnostic catheter, same shape and size was used to complete the procedure.The procedure was a standard diagnostic for the left coronary artery (lca).The device was handled according to the instruction for use (ifu).There were no difficulties removing the product from the packaging.There were no damages to the device packaging.There were no excessive force used.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
When opening the pouch and preparing the 6f 100cm judkins right (jr4) infiniti diagnostic catheter, the sterile nurse identified a small hole approximately 15cm distal of the tip.Therefore, a new unknown catheter was opened and used for the patient.There was no reported patient injury.A new diagnostic catheter, same shape and size was used to complete the procedure.The procedure was a standard diagnostic for the left coronary artery (lca).The device was handled according to the instruction for use (ifu).There were no difficulties removing the product from the packaging.There were no damages to the device packaging.There was no excessive force used.The product was returned for analysis.Per visual analysis, a puncture was noted on the body of the unit.No other anomalies were found along the device.A functional analysis was not performed.Per sem analysis, the torn area of the cath f6 inf tl jr 4 100 cm device unit presented evidence of scratch marks and elongations along the torn area on the body/shaft material.This type of damage is commonly caused during the interaction of the body/shaft material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the body/shaft could probably led to the torn condition found on the received device.It appears that the catheter material near the rupture was torn either due to the interaction of the catheter with calcified spicules located on the lesion or with a sharp object from the outside of the catheter.No other anomalies were observed during the analysis.A product history record (phr) review of lot 17948703 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) ¿ puncture/cut - during prep¿ was confirmed during visual analysis since a puncture was found on the unit.The exact cause of this condition could not be conclusively determined during the analysis.Procedural and/or handling factors, such as operator technique, or vessel characteristics, although unknown, may have contributed to the reported event.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.No corrective or preventive actions will be taken.According to the ifu, which is not intended as a mitigation of risk, ¿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.¿ neither the phr nor the product analysis available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: CATH F6INF TL JR 4 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11108439
• Report Number: 9616099-2021-04169
• Device Sequence Number: 3950003
• Product Code: DQO
• UDI-Device Identifier: 10705032014199
• UDI-Public: 10705032014199
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: 04/30/2023
• Device Model Number: 534621T
• Device Catalogue Number: 534621T
• Device Lot Number: 17948703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2020
• 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: UNK NEW CATHETER