MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO GC 5F 056 JR 4 STAND TIP; CATHETER, PERCUTANEOUS

Model Number 55608200

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted, and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During use in patient, the 5f.056 vista brite tip judkins right 4 (jr) guiding catheter (gc) was leaking.There was no reported patient injury.The catheter was stored per the ifu.The catheter was injected with contrast as it was entering the patient.The doctor noticed a small leak at that point.It was removed with no negative outcome.The device will be returned for evaluation.No other information was provided.

Manufacturer Narrative

This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information was received and the manufacturing (section h4) and expiration (section d4) dates were added to this report.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information was received and the lot number does not match the product number.The device received and lot number is for a infiniti catheter; not a brite tip guiding catheter.Therefore the product number was update to reflect the lot number and device received.Section d1 and d2 were updated to include: brand name: ducor, dqo - catheter, intravascular, diagnostic.Section d4 was updated to include: model#: 534597t, gtin#: (b)(4).A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: during use in patient, the 5f infiniti catheter propac was leaking.There was no reported patient injury.The catheter was stored per the instructions for use (ifu).The catheter was injected with contrast as it was entering the patient.The doctor noticed a small leak at that point.It was removed with no negative outcome.No other information was provided.One non-sterile unit of cath propac 5finf 035gw pig145 was received for analysis.During the visual inspection, exposed wire is noted, however amplified images were taken to better observe the damage (see microscopic analysis section).No other damages or anomalies were observed with the naked eye.Functional analysis was performed.A flushing test was performed on the unit and a leakage was noted at 74.7 cm from distal tip.A puncture/hole was noted and through this damage the liquid was leaking.Additionally, another leak was noted near the exposed wire, and another apparent puncture/hole could be the damage that caused the leak.As per visual analysis exposed wire is present at 78.2 cm from distal tip.Due to the exposed wire, an x-ray analysis was performed, to see the condition of the braidwire.Where the exposed braidwire was, it could be noted a disordered braided.Also, near the damage, an unusual braid is also observed.The unit was analyzed under x-ray along the unit, from the hub, to the distal tip, to look for anomalies on the braid.Only near the damage anomalies were found.Since a puncture was found, a sem analysis was performed and the results showed that the outer surface of the catheter unit presented bulged/peeled off material along the puncture/hole.The inner surface presented evidence of scratch marks and bulged/peeled off material near the puncture/hole.This type of damage is commonly caused during the interaction of the catheter material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and bulged/peeled off material on the unit¿s inner surface probably led to the punctured condition found on the received unit.It seems the catheter material was punctured with a sharp object from the inside of the unit.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17988474 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The ¿catheter (body/shaft)- leakage - in-patient¿ and "catheter (body/shaft) - puncture/hole" reported by the customer were confirmed since a leakage was noted during functional test through an apparent hole.The unit was sent for additional analysis and it was determined that an additional puncture/hole was a void related to the manufacturing process of the body/shaft.Thus, an escalation process was initiated to address the investigation.The ¿catheter (body/shaft)- exposed braidwire/corewire¿ found during product analysis, was confirmed since exposed wire was noted during the analysis.X-ray analysis was performed, and it was noted that the braid of the wire has an unusual form.The secondary failure found was considered as potentially related to the manufacturing process and a risk assessment has been initiated.Users are trained to inspect for kinks and bends, or other signs of damage prior to and during use, as was done in this case.Any product with damage is not to be used.The reported conditions are considered to be related to the manufacturing process as confirmed through the product evaluation.Therefore, the event has been escalated and a risk assessment has been initiated.

Event Description

During use in patient, the 5f infiniti catheter propac was leaking.During fal analysis, it was noted that the wire was exposed on the body of the catheter.There was no reported patient injury.The catheter was stored per the ifu.The catheter was injected with contrast as it was entering the patient.The doctor noticed a small leak at that point.It was removed with no negative outcome.The device will be returned for evaluation.No other information was provided.Addendum: product analysis demonstrates a leakage was noted from distal tip and a puncture/hole is noted, through this damage the liquid was leaking.The results showed that the outer surface of the catheter unit presented bulged/peeled off material along the puncture/hole.

• Brand Name: GC 5F 056 JR 4 STAND TIP
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11344559
• MDR Text Key: 233591768
• Report Number: 9616099-2021-04278
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032064207
• UDI-Public: 20705032064207
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 55608200
• Device Catalogue Number: 55608200
• Device Lot Number: 17988474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1