MAUDE Adverse Event Report: CORDIS US. CORP PALMAZ BLUE ON AVIATOR PLUS; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Catalog Number PB1840PPX

Device Problem Deflation Problem (1149)

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

Event Date 11/21/2023

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82234548 presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after releasing the stent of a 4mm x 18mm palmaz blue on aviator plus stent delivery system (sds) to treat vertebral artery stenosis, the balloon was unable to be deflated.As a result, the delivery system was intentionally cut, and the balloon was deflated with a syringe.The entire system was then withdrawn from the patient and the procedure was completed.The stent remained implanted and did not migrate as a result of the deflation difficulty.The device was stored and prepped per the instructions for use (ifu) and there were no difficulties removing any of the sterile packaging components.The lesion had moderate calcification, mild tortuosity, and a 75% stenosis.A non-cordis balloon catheter was used to pre-dilate the lesion.The aviator plus sds was not kinked at any time during this procedure.The device will be returned for evaluation.

• Brand Name: PALMAZ BLUE ON AVIATOR PLUS
• Type of Device: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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 CR 2 -01 0 ; CS CR 2 01 02 ; 7863138372
• MDR Report Key: 18586545
• MDR Text Key: 333839526
• Report Number: 3007635982-2024-00016
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032062166
• UDI-Public: (01)20705032062166(17)231130(10)82234548
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: PB1840PPX
• Device Lot Number: 82234548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABBOT BALLOON; PB STENT; TEMPO CONTRAST TUBE
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 75 KG