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

Catalog Number PB1850PPX

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 05/12/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, there was a hole in the shaft of a 5mm x 20mm 142cm palmaz blue on aviator plus stent delivery system (sds).There was no reported injury to the patient and the device will not be returned for evaluation.

Manufacturer Narrative

After further review of additional information received.Complaint conclusion: there was a hole in the shaft of a 5mm x 20mm 142cm palmaz blue on aviator plus stent delivery system (sds).There was no reported injury to the patient.Additional information was requested but was not provided.The product was not returned for analysis.A product history record (phr) review of lot 82246469 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft frayed/split/torn¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors or vessel characteristics (although unknown) may have contributed to the reported event.According to the precautions in the safety information in the instructions for use ¿prior to use, the product should be examined to verify functionality and integrity.¿ neither the phr review nor the very limited information provided suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, there was a hole in the shaft of a 5mm x 20mm 142cm palmaz blue on aviator plus stent delivery system (sds).There was no reported injury to the patient.Additional information was requested but was not provided.The device will not 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, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; coyol free zone, building b25, , , costa rica; el coyol alajuela bld 25 ; 7863138372
• MDR Report Key: 17075578
• MDR Text Key: 316695063
• Report Number: 3007635982-2023-00206
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PB1850PPX
• Device Lot Number: 82246469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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