MAUDE Adverse Event Report: CATH TEMPO 4F UF 65CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	451404V5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
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.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
During a peripheral angiogram, the distal end of a 4f 5 side holes (5sh) 65cm universal flush tempo diagnostic catheter broke off.The physician was able to retrieve the device.The device was stored as per labeling and opened in a sterile field.The device will be returned for evaluation.
Additional Manufacturer Narrative
During a peripheral angiogram, the distal end of a 4f 5 side holes (5sh) 65cm universal flush tempo diagnostic catheter broke off.The physician was able to retrieve the device.The device was stored as per labeling and opened in a sterile field.Additional procedural details were requested but not provided.One non-sterile tempo catheter (cath tempo 4f uf 65cm 5sh) was received for analysis.During the visual analysis it was noted that the catheter was separated.Sem analysis was performed in order to determine the separation cause.Results showed the separated area of the body/shaft of the tempo catheter presented evidence of cup and cone shaped-like elongations.These characteristics are commonly associated with separations caused by material tensile overload.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 17991292 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The failure reported by the customer as ¿brite tip/distal tip - catheters- separated in patient¿ was confirmed since the returned catheter was found separated.However, per sem analysis it was determined the cause of the separation was associated with separations caused by material tensile overload.Procedural/handling factors or vessel characteristics, although not provided, may have contributed to the reported event.According to the instructions for use (ifu), which is 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.Treat all 4f 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.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 phr review nor the product analysis suggest that the separated 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 65CM 5SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11828578
• Report Number: 9616099-2021-04548
• Device Sequence Number: 3663569
• Product Code: DQO
• UDI-Device Identifier: 20705032007730
• UDI-Public: 20705032007730
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: 11/30/2023
• Device Model Number: 451404V5
• Device Catalogue Number: 451404V5
• Device Lot Number: 17991292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention