MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F UF 90CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451404F5
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information to include from section e phone number: (b)(6).A review of the manufacturing records could not be conducted without a lot number.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
Doing a procedure, a wire went through the tempo catheter.There was no patient injury.The device was handled according to the instruction for use (ifu).There was no difficulties removing the product from the packaging.The device is available for analysis.No other information was provided.
Additional Manufacturer Narrative
During a procedure, a wire went through the tempo catheter.There was no patient injury.The device was handled according to the instruction for use (ifu).There was no difficulty removing the product from the packaging.No other information was provided.A non- sterile unit of product ¿cath tempo 4f uf 90cm 5sh¿ was received for analysis.Neither a puncture nor a cut was noticed on the returned device.A kinked/bent condition was observed located at 38cm from the hub.No other damages or anomalies on the device were detected.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od).Measurements were taken near the damage.Dimensional analysis results were found within specification.A product history record (phr) review could not be performed since the complaint lot is unknown.The complaint reported by the customer as ¿catheter (body/shaft) - puncture/cut¿ was not confirmed.Neither a puncture nor a cut was observed on the returned catheter.However, a kinked/bent condition was noticed on the body of the catheter.Exact cause of the damage could not be conclusively determined during the analysis.Dimensional analysis results were found within specification.Procedural/handling factors might have contributed to this issue.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿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.Treat all 4f (1.35 mm) catheters and smaller french sizes with ultimate care.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 nor the information available suggests that the found kinked condition 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 TEMPO 4F UF 90CM 5SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 9215540
• Report Number: 9616099-2019-03291
• Device Sequence Number: 19463918
• Product Code: DQO
• UDI-Device Identifier: 10705032007726
• UDI-Public: 10705032007726
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

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 Model Number: 451404F5
• Device Catalogue Number: 451404F5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1