MAUDE Adverse Event Report: CORDIS US CORP BRITE TIP; INTRODUCER, CATHETER

Catalog Number	401605M
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	09/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the tip of the 6f 5.5cm brite tip sheath introducer broke; the radiopaque tip separated from the rest of the catheter and embedded in the patient, resulting in two pieces.There was no reported patient injury.No anomalies were noted when the product was removed from the package.The product was stored and handled according to the instructions for use (ifu), and it was inspected and prepped per the ifu without any difficulty.No resistance or friction was experienced during any part of the procedure, and no resistance was met while advancing the device.Unusual force was not necessary during the use of the device, and excessive torquing was not required.The tip was visible on fluoroscopy throughout the procedure.The exam was complete at this point, and another brite tip sheath was not used.The customer pulled the box off the shelf and did not confirm if they would be returning the unused units left in the box or if they wanted a credit or reorder.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As per radiology report, the intended procedure was reported to be a left arm fistulogram with balloon angioplasty of the basilic vein.The left arm was prepped and draped in the usual sterile fashion and 1% lidocaine was used for local anesthesia.The fistula evaluated with ultrasound was accessed retrograde using micropuncture technique and ultrasound guidance.Through the micropuncture sheath, a non-cordis wire was then advanced peripherally.The micropuncture sheath was exchanged for an unknown 6f sheath through which a 6 mm x 4 cm powerflex balloon was used to angioplasty the multifocal basilic vein stenosis.The balloon was deflated and the completion fistolugram was performed.Purse string suture was applied and the sheath was removed.Upon sheath removal, a small piece of this sheath had broken off in the subcutaneous tissues and was unable to be removed.Hemostasis was achieved.The patient tolerated the procedure well and left the interventional radiology department in stable condition.Ultrasound images demonstrated moderate narrowing of the fistula throughout the elbow with some aneurysmal dilatation.A tiny piece of the sheath broke off and was retained in the subcutaneous tissue.The customer pulled the box off the shelf and did not confirm if they would be returning the unused units left in the box or if they wanted a credit or reorder.
Event or Problem Description
A single cd-rom containing fourteen images was submitted and reviewed by an independent physician.
Additional Manufacturer Narrative
As reported, the tip of the 6f 5.5cm brite tip sheath introducer broke; the radiopaque tip separated from the rest of the catheter and embedded in the patient, resulting in two pieces.There was no reported patient injury.No anomalies were noted when the product was removed from the package.The product was stored and handled according to the instructions for use (ifu), and it was inspected and prepped per the ifu without any difficulty.No resistance or friction was experienced during any part of the procedure, and no resistance was met while advancing the device.Unusual force was not necessary during the use of the device, and excessive torquing was not required.The tip was visible on fluoroscopy throughout the procedure.The exam was complete at this point, and another brite tip sheath was not used.As per radiology report, the intended procedure was reported to be a left arm fistulagram with balloon angioplasty of the basilic vein.The left arm was prepped and draped in the usual sterile fashion and 1% lidocaine was used for local anesthesia.The fistula evaluated with ultrasound was accessed retrograde using micro puncture technique and ultrasound guidance.Through the micro puncture sheath, a non-cordis wire was then advanced peripherally.The micro puncture sheath was exchanged for an unknown 6f sheath through which a 6 mm x 4 cm powerflex balloon was used to angioplasty the multifocal basilic vein stenosis.The balloon was deflated and the completion fistulagram was performed.Purse string suture was applied and the sheath was removed.Upon sheath removal, a small piece of this sheath had broken off in the subcutaneous tissues and was unable to be removed.Hemostasis was achieved.The patient tolerated the procedure well and left the interventional radiology department in stable condition.Ultrasound images demonstrated moderate narrowing of the fistula throughout the elbow with some aneurysmal dilatation.A tiny piece of the sheath broke off and was retained in the subcutaneous tissue.The customer pulled the box off the shelf and did not confirm if they would be returning the unused units left in the box or if they wanted a credit or reorder.The device was not returned for evaluation.A single cd-rom containing fourteen images was submitted and reviewed by an independent physician.This event involves a dialysis patient undergoing treatment of a fistula stenosis.At the end of the procedure the treating physician noted that the tip of a brite tip sheath had fractured and a fragment remained in the fistula.There is a patent fistula with high grade stenosis just distal to the anastomosis.The sheath is not seen.Multiple images show angioplasty of the fistula.The sheath is not included in any of these images.The last angioplasty image shows balloon dilatation of the vessel segment immediately adjacent to the sheath.The balloon is just partly in the sheath.A tiny radiopaque fragment is now seen adjacent to the sheath.Final image shows good angioplasty result.The fragment is unchanged in position.Full evaluation of this event is limited due to limited images and clinical information provided for review.The fact that the separated piece is just a fragment rather than the entire tip of the sheath leads to believe that this may be procedurally related.On one image we see the angioplasty balloon partly within the sheath.If the entire tip of the sheath had separated, i would be concerned about a manufacturing defect.The information provided in this case does not support this.Without the return of the device or images for analysis, the reported customer event ¿brite tip/distal tip-separated¿ could not be confirmed and the root cause cannot be determined.Procedural factors may have contributed to the reported event.Per the independent physician, in 2024, these events are uncommon.Percutaneous retrieval can be difficult.One technique is to obtain access in the direction of the fragment and place the sheath close to the fragment.Then the outflow is manually occluded and brisk aspiration of the sheath is performed to draw the fragment into the sheath.Alternatively, a looped snare device such as en snare can be used to try to retrieve the fragment.If the fragment cannot be retrieved the risk is central embolization.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.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), although not intended as a mitigation of risk, ¿if increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure, and withdraw the csi.¿ based on the available information, 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: BRITE TIP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 20295408
• Report Number: 9616099-2024-00321
• Device Sequence Number: 15485655
• Product Code: DYB
• UDI-Device Identifier: 10705032000222
• UDI-Public: (01)10705032000222(17)270630(10)18337522
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/11/2024

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 Catalogue Number: 401605M
• Device Lot Number: 18337522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 11/25/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/27/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2024
• 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: UNKNOWN.
• Patient Age: 69 YR
• Patient Sex: Male