MAUDE Adverse Event Report: CATH F6INF TL JL 5 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Three pictures were received for picture analysis related to complaint # case-(b)(4).Per visual analysis of the attached pictures, a coiled cath f6inf tl jl 5 100cm unit was observed.The body/shaft of the unit was observed cracked near to the distal tip.No other anomalies were observed.The event reported by the customer as ¿catheter (body/shaft) - cracked - during prep¿ was confirmed since the body/shaft of the unit was observed cracked near to the distal tip, by picture analysis.However, the exact cause of the cracked body/shaft cannot be conclusively determined based on the picture visual analysis sole information provided.Nonetheless, neither the phr review nor the picture review suggest that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
A 6f 100cm jl 5 infiniti thrulmen diagnostic catheter had a crack in the distal end and was it was noticed when device was being prepped for use.The device never entered the patient, and no harm was caused.It was initially reported "wire looks like it was damage during manufacturing.There is a snip out if it near the j end." this product does not contain a wire.The device will be returned for evaluation.3 images were provided for review.
Additional Manufacturer Narrative
The device was returned and section d9 was updated accordingly.The completed engineering report will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, a 6f 100cm jl 5 infiniti thrulmen diagnostic catheter had a crack in the distal end, which was noted during prep.The initial report stated ¿wire looks like it was damaged during manufacturing.There is a snip out if it near the j end.¿ however, this device is not a wire.The device never entered the patient.There was no reported patient injury.Three pictures were received for analysis.Per visual inspection, a coiled cath 6f inf tl jl 5 100cm unit was observed.Additionally, the body/shaft of the unit presented with a crack near the distal tip.No other anomalies were observed during photo analysis.One non-sterile cath 6f inf tl jl 5 100cm unit was received for analysis.During visual inspection, a crack was noted on the body approximately 8 cm from the distal tip.No other anomalies were observed during the visual analysis.Sem analysis results revealed elongations and scratch marks on the outer surface of the body/shaft material near the cracked area.Additionally, the braid wire on the body/shaft were noted to be sheared off.No other anomalies were observed during sem analysis.A product history record (phr) review of lot 17946069 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer ¿catheter (body/shaft) ¿ cracked - during prep¿ was confirmed since a cracked condition was found on the body of the unit.The sheared off material observed on the braid wire is commonly caused by an interaction with a sharp object.Elongations and scratch marks were also found on the outer surface of the affected area.Therefore, it is assumed the unit was torn/cracked from an interaction with a sharp object such as a separate medical device.Handling factors may have contributed to the reported event.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Although not intended as a mitigation of risk, information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), ¿store in a cool, dark, dry place.Do not use open or damaged packages.To prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.¿ based on the information available, product analysis, and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: CATH F6INF TL JL 5 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 12301758
• Report Number: 9616099-2021-04772
• Device Sequence Number: 3970400
• Product Code: DQO
• UDI-Device Identifier: 10705032014205
• UDI-Public: (01)10705032014205(17)230331(10)17946069
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2021

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 67000800
• Device Lot Number: 17946069
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 08/25/2021; 09/22/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/02/2021; 09/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• 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.; UNK.
• Patient Age: 74 YR