MAUDE Adverse Event Report: CATH TEMPO 5F PIG 110CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451503L5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot#: 17633817 presented no issues during the manufacturing process that can be related to the reported complaint.This device is available for analysis but the engineering report is not yet available.The product was returned for analysis.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, a 5f 110cm 5 side holes (sh) pigtail tempo catheter was found broken into to two pieces, when they opened it.It was also noted that the device was opened beyond the expiration date but it was not used in the patient.There was no reported patient injury.The product was stored as per labeling.There was no difficulty removing the product from the hoop, protective balloon cover, stylet or any of the sterile packaging components.The device was opened in a sterile field.The device will be returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g4, g7, h1, h2, h3 and h6.As reported, a 5f 110cm 5 side holes (sh) pigtail tempo catheter was found broken into to two pieces, when they opened it.It was also noted that the device was opened beyond the expiration date but it was not used in the patient.There was no reported patient injury.The device was opened in a sterile field.A non-sterile tempo diagnostic catheter (cath tempo 5f pig 110cm 5sh) was received for analysis.Per visual analysis, the pigtail tip of the unit was found separated at 4.5cm from the distal end of the catheter.Also, a kink was found on the separated pigtail tip at 1.5cm from the tip end.No other anomalies were found.Expiration date verification was performed and it was concluded that based on engineering specifications, the expiration date was within the specified use by date (ubd) requirements at the time of sale.Per dimensional analysis, the catheter tip outer diameter (od) and inner diameter (id) near the separation and kink condition were measured and the results were found within specification.Pull test functional analysis was not performed due to no sterile units returned.Per microscopic analysis, the separated catheter body/shaft and the distal tip of the unit were inspected and the edges on both the separated tip and the catheter body/shaft were observed elongated.The separated distal tip of the unit was sent to sem analysis to determine the root cause of the observed characteristic.Sem results showed that the observed tip separated area presented a pattern that shows evidence of material elongations, which are commonly associated with separations caused by material tensile overload.Also, diameter reduction was observed.The elongations found on the tip material, as well as the diameter reduction, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the tip material was induced to a tensile force that exceeded the tip material yield strength prior to the separation.No other issues were noted during sem analysis.A product history record (phr) review of lot 17633817 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 ¿packaging/pouch/box- expiration date exceeded¿ was confirmed since the unit expired on 12/31/2019.However, per event description, it was reported that the device was opened beyond the expiration date and not used in the patient.The shelf life of the unit indicates that the lot met specified expiration date requirements.The expiration date was within the specified use by date (ubd) requirements at the time of sale.The exact cause of the device opening for use beyond expiration date event could not be conclusively determined during the analysis.The complaint reported by the customer as ¿catheter (body/shaft)- separated ¿ during prep¿ was also confirmed during the analysis due to the separated condition of the distal tip of the unit received.However, microscopic review and analysis results showed evidence of elongations and diameter reduction on the distal tip.The elongations and diameter reduction suggest that the device was induced to stretching/pulling events that exceeded the material yield strength before the distal tip separation occurred.The exact cause of the separated distal tip could not be conclusively determined during the analysis.Procedural/handling factors may have contributed to the distal tip separated damage condition.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.According to 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.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ neither the phr review nor the product analysis results suggest that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken.

• Brand Name: CATH TEMPO 5F PIG 110CM 5SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 10520705
• MDR Text Key: 206964351
• Report Number: 9616099-2020-03897
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032008287
• UDI-Public: 20705032008287
• Combination Product (y/n): N
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 451503L5
• Device Catalogue Number: 451503L5
• Device Lot Number: 17633817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1