MAUDE Adverse Event Report: CORDIS US. CORP MAXI LD; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	4171460S
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
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 balloon of a 14mm x 6cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheter was caught during the procedure and fell off.The balloon was caught during removal from a non-cordis stent and the separation occurred while trying to withdraw the balloon catheter.There were attempts to retrieve the separated segment from the patient using an unknown device; however, the retrieval was unsuccessful, and the patient was transported by ambulance to the hospital for surgery.The separated segment was successfully removed during the surgical intervention.The target vessel was the iliac vein, which was neither calcified nor tortuous.The separation occurred in the iliac vein.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components or the protective balloon cover.The device maintained negative pressure during preparation.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, d4, d9, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, the balloon of a 14mm x 6cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheter was caught during the procedure and fell off.The balloon was caught during removal from a non-cordis stent and the separation occurred while trying to withdraw the balloon catheter.There were attempts to retrieve the separated segment from the patient using an unknown device; however, the retrieval was unsuccessful, and the patient was transported by ambulance to the hospital for surgery.The separated segment was successfully removed during the surgical intervention.The target vessel was the iliac vein, which was neither calcified nor tortuous.The separation occurred in the iliac vein.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components or the protective balloon cover.The device maintained negative pressure during preparation.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 82322550 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, the reported customer complaint of ¿balloon separated and pta/ptca system withdrawal difficulty through a previously deployed stent¿ could not be observed.Without the return of the device and with no procedural films or images, it is not possible to draw a conclusion about a clinical relationship between the device and the event.The cause of the reported event could not be determined.It is possible that factors related to the procedure, handling, and/or patient anatomy contributed to the reported event.However, interaction between the previously implanted stent and the balloon can create circumstances in which the balloon may get caught and friction from attempting to disengage the device from the stent can cause material to weaken and separate.According to the safety information in the instructions for use ¿note: the rated burst pressure is printed on the package label.In vitro testing has shown that with 95% confidence, 99.9% of the balloons will not burst at or below the rated pressure.Balloons should not be inflated in excess of the rated burst pressure.To reduce the potential for vessel damage, the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the stenosis.¿ based on the information available for review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no corrective/preventative actions will be taken at this time.
Event or Problem Description
As reported, the balloon of a 14mm x 6cm maxi ld percutaneous transluminal angioplasty (pta) balloon catheter was caught during the procedure and fell off.The balloon was caught during removal from a non-cordis stent and the separation occurred while trying to withdraw the balloon catheter.There were attempts to retrieve the separated segment from the patient using an unknown device; however, the retrieval was unsuccessful, and the patient was transported by ambulance to the hospital for surgery.The separated segment was successfully removed during the surgical intervention.The target vessel was the iliac vein, which was neither calcified nor tortuous.The separation occurred in the iliac vein.The device was stored and prepped per the instructions for use (ifu).There was no difficulty removing any of the sterile packaging components or the protective balloon cover.The device maintained negative pressure during preparation.The device was not returned as expected.

• Brand Name: MAXI LD
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 22168095
• Report Number: 3007635982-2025-00121
• Device Sequence Number: 7829273
• Product Code: LIT
• UDI-Device Identifier: 20705032002452
• UDI-Public: (01)20705032002452(17)260331(10)82322550
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963000
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 4171460S
• Device Lot Number: 82322550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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 DEVICE; WALL STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 53 KG