MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO GC 5F 056 XB 3.5 LBT; CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned but the engineering report is pending.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.
Event or Problem Description
Upon the removal of a 5f.056¿ extra back-up (xb) long brite tip (lbt) guiding catheter, the guiding catheter kinked and deformed as it was withdrawn from over the subclavian arch.The catheter was then not able to be withdrawn through the sheath (unknown), which led to further deformity.This issue provoked an injury, the vessel damage n the radial due to trauma from the removal of the deformed catheter.The device will be returned for evaluation.
Additional Manufacturer Narrative
While removing a 5f.056¿ extra back-up long brite tip guiding catheter, it kinked and deformed as it was withdrawn over the subclavian arch.The catheter could not be withdrawn through the unknown sheath, which led to further deformity.The event led to an injury of the radial blood vessel.A non-sterile unit of a long brite tip catheter (gc 5f 056 xb 3.5 lbt) was received inserted into a non-cordis csi.During the visual analysis, a compressed/crushed condition was found from the cm 37 to cm 39 from the distal tip, a kink condition was also found at 51 cm from the distal tip.In addition, the cannula in which the guiding catheter was inserted, was returned with an accordioned condition.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od).Measurements were taken near the damages.Dimensional analysis results were found within specification.During functional analysis, a guidewire was inserted with difficulty through the guiding catheter.Additionally, the guiding catheter was inserted into a lab sample 5f catheter sheath introducer and it encountered insertion/withdrawal difficulty.A product history record (phr) review of lot 18010131 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without procedural films or images, the reported ¿injury to radial blood vessels¿ cannot be confirmed and the exact root cause cannot be determined.The complaints reported by the customer ¿catheter (body/shaft) ¿ kinked/bent - in-patient¿ and ¿catheter (body/shaft)-withdrawal difficulty - through sheath¿ were confirmed through analysis of the received product.The catheter presented a kink/bent condition on the body of the catheter along with a compressed condition.Exact cause of this damage noticed on the device could not be conclusively determined during the analysis.Dimensional analysis results were found within specification.Procedural/handling factors or vessel characteristics might have contributed to this issue.Catheter kinking during clinical use is a known and common occurrence during the procedure and is typically related to anatomy, technique, skill, and vessel tortuosity.Kinking of the catheter body/shaft may have led to withdrawal difficulty through the sheath.According to the instructions for use, although not intended as a mitigation of risk, ¿inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.If strong resistance is met during manipulation, discontinue the procedure, and determine the cause of the resistance before proceeding.If the cause of the resistance cannot be determined, withdraw the catheter.Advancement, manipulation, and withdrawal of the guiding catheter should always be performed under fluoroscopic guidance.Extreme care must be taken to avoid damage to the vasculature through which the guiding catheter passes.The guiding catheter may occlude smaller vessels.Care must be taken to avoid complete blood flow blockage.Remove the guiding catheter from its packaging.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
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.

• Brand Name: GC 5F 056 XB 3.5 LBT
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11991253
• Report Number: 9616099-2021-04633
• Device Sequence Number: 3268946
• Product Code: DQY
• UDI-Device Identifier: 20705032015223
• UDI-Public: 20705032015223
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K000715
• 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,Followup,Followup
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 5560540L
• Device Lot Number: 18010131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/09/2021; 08/02/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 06/17/2021; 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SHEATH; UNKNOWN SHEATH
• Outcome Attributed to Adverse Event: Required Intervention