MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO AQUA 5F SIM 2 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	452531H0
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a cerebral angiography, the physician used a 5f tempo aqua diagnostic catheter and the catheter broke inside the patient.There was resistance met while advancing the device and resistance met while withdrawing the device because the patient had very tortuous and calcified arteries and therefore it wasn¿t easy to move the catheter.The physician removed the lost piece with a snare.The patient is alive.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The event did not cause a clinically relevant increase in the duration of the procedure.There was severe calcification of the lesion.There was moderate vessel tortuosity.The device was not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.There is no procedural cd available for review.Other additional patient/procedural details were requested but were unknown.The device was not returned for analysis.A product history record (phr) review of lot 17873314 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis, the reported ¿catheter (body/shaft) ¿ separated-in-patient,¿ ¿catheter (body/shaft) -withdrawal difficulty - from vessel¿, and ¿catheter (body/shaft)- tracking difficulty¿ could not be confirmed and the exact root cause could not be determined.Vessel characteristics (moderately tortuous and severely calcified arteries) and/or procedural/handling factors may have contributed to the reported events.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.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure." neither the information available nor the phr results suggest that the reported events could be related to the manufacturing process.Therefore, no corrective action will be taken at this time.
Event or Problem Description
During a cerebral angiography, the physician used a 5f 2 100cm tempo aqua sidewinder simmons technique ii (sim2) angiographic catheter and the catheter broke inside the patient.There was resistance met while advancing the device and resistance met while withdrawing the device because the patient had very tortuous and calcified arteries and therefore it wasn¿t easy to move the catheter.The physician removed the lost piece with a snare.The patient is alive.The event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.The event did not cause a clinically relevant increase in the duration of the procedure.There was severe calcification of the lesion.There was moderate vessel tortuosity.The device was not resterilized.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.There is no procedural cd available for review.Other additional patient/procedural details were requested but were unknown.The device is expected to be returned for analysis.

• Brand Name: CATH TEMPO AQUA 5F SIM 2 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9963797
• Report Number: 9616099-2020-03648
• Device Sequence Number: 2750315
• Product Code: DQO
• UDI-Device Identifier: 20705032009048
• UDI-Public: 20705032009048
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K000579
• 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
• Report Date (Section B): 04/15/2020

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: 05/31/2022
• Device Model Number: 452531H0
• Device Catalogue Number: 452531H0
• Device Lot Number: 17873314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention