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

Model Number PB1550PPX

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

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

Event Date 01/02/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.

Event Description

As reported, there was a small hole in the balloon of the blue/aviator/plus 5x15 device.The hole was noticed during prep of the device.The case was completed with the use of an unknown device.The case was completed with the use of an unknown device.There was no reported injury to the patient.The device was stored in a locker in the storage room of the cath lab.The device was stored per the ifu.There was no difficulty removing the device from the hoop.The device was prepped per the ifu and was able to maintain negative pressure.The device will be returned for evaluation.

Manufacturer Narrative

This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, there was a small hole in the balloon of the blue/aviator/plus 5x15 device.The hole was noticed during prep of the device.The case was completed with the use of an unknown device.The case was completed with the use of an unknown device.There was no reported injury to the patient.The device was stored in a locker in the storage room of the cath lab.The device was stored per the ifu.There was no difficulty removing the device from the hoop.The device was prepped per the ifu and was able to maintain negative pressure.The device will not be returned for evaluation as multiple attempts were made without success.

Event Description

As reported, there was a small hole in the balloon of the blue/aviator/plus 5x15 device.The hole was noticed during prep of the device.The case was completed with the use of an unknown device.The case was completed with the use of an unknown device.There was no reported injury to the patient.The device was stored in a locker in the storage room of the cath lab.The device was stored per the ifu.There was no difficulty removing the device from the hoop.The device was prepped per the ifu and was able to maintain negative pressure.The device will not be returned for evaluation as multiple attempts were made without success.

Manufacturer Narrative

There was a small hole in the balloon of the blue/aviator/plus 5x15mm device.The hole was noticed during prep of the device.The case was completed with the use of an unknown device.There was no reported injury to the patient.The device was stored in a locker in the storage room of the cath lab.The device was stored per the instructions for use (ifu).There was no difficulty removing the device from the hoop.The device was prepped per the ifu and was able to maintain negative pressure.The product was not returned for analysis.A product history record (phr) review of lot 82246420 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon-sds frayed/split/torn - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors 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 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.

Manufacturer Narrative

There was a small hole in the balloon of the blue/aviator/plus 5x15mm device.The hole was noticed during prep of the device.The case was completed with the use of an unknown device.There was no reported injury to the patient.The device was stored in a locker in the storage room of the cath lab.The device was stored per the instructions for use (ifu).There was no difficulty removing the device from the hoop.The device was prepped per the ifu and was able to maintain negative pressure.The product was returned for analysis.One non-sterile unit of a blue/aviator/plus 5x15/142p stent delivery system was received inside of a clear plastic bag.Per visual analysis, the balloon looks like it was not attempted to be inflated.No anomalies were noted.Per functional analysis an insertion/withdrawal of an appropriate guide wire through the hub and the distal tip was completed with no difficulties.Then, an inflator/deflator was connected to the device and, the balloon presented a leakage at the proximal section.Per sem analysis the leakage on the balloon of the device was caused by a puncture/cut on the component that presented evidence of scratch marks near the damage.The scratch marks are commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon led to the damaged condition found.It seems the material near the puncture/cut was caused by a sharp object from the outside of the device since the damages are noted on the external surface.No other anomalies were observed.A product history record (phr) review of lot 82246420 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon-sds ¿ frayed/split/torn - during prep¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the event as evidenced by scratch marks noted on the outer surface during analysis.Per sem analysis the leakage on the balloon of the device was caused by a puncture/cut on the component that presented evidence of scratch marks near the damage.The scratch marks are commonly caused during the interaction of the material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks on the balloon led to the damaged condition found.It seems the material near the puncture/cut was caused by a sharp object from the outside of the device since the damages are noted on the external surface.According to 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 product analysis 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 small hole in the balloon of the blue/aviator/plus 5x15 device.The hole was noticed during prep of the device.The case was completed with the use of an unknown device.The case was completed with the use of an unknown device.There was no reported injury to the patient.The device was stored in a locker in the storage room of the cath lab.The device was stored per the ifu.There was no difficulty removing the device from the hoop.The device was prepped per the ifu and was able to maintain negative pressure.The device was 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 CASHEL; cahir road; cashel, co. tipperary; miami lakes FL ; EI
• Manufacturer (Section G): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16215050
• MDR Text Key: 308463603
• Report Number: 9616099-2023-06227
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 20705032062104
• UDI-Public: (01)20705032062104(17)240229(10)82246420
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: PB1550PPX
• Device Catalogue Number: PB1550PPX
• Device Lot Number: 82246420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• 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
• Treatment: UNKNOWN DEVICE; UNKNOWN DEVICE
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 55 KG