MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, STEERABLE

Lot Number 0030157559

Device Problems Use of Device Problem (1670); Air/Gas in Device (4062)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

It was reported that the sheath port contained air after attempted aspiration.During a procedure a crbs polarsheath steerable sheath was selected for use.When the sheath was in the body of the patient the tip of the balloon catheter was inserted and an attempt was made to draw reverse blood, but it couldn't be pulled.At the same time, when negative pressure was not applied and reverse blood was drawn while advancing further, fine air was confirmed in the sheath port.Afterwards, the air was able to be removed and the procedure was completed using the sheath.No patient complications were reported.The device is expected to be returned for analysis.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

The polarsheath was returned to boston scientific for laboratory analysis.A visual inspection was performed, and no abnormalities were observed.A functional test was performed that included an aspiration test, a hemostasis valve test, and air pressure test.The sheath passed all standard manufacturing testing.The sheath was able to hold pressure while pressurized at 5.5 psi in hemostasis testing.Laboratory analysis was unable to confirm the reported clinical observation.

Event Description

It was reported that the sheath port contained air after attempted aspiration.During a procedure a crbs polarsheath steerable sheath was selected for use.When the sheath was in the body of the patient the tip of the balloon catheter was inserted and an attempt was made to draw reverse blood, but it couldn't be pulled.At the same time, when negative pressure was not applied and reverse blood was drawn while advancing further, fine air was confirmed in the sheath port.Afterwards, the air was able to be removed and the procedure was completed using the sheath.No patient complications were reported.The device has been returned for analysis.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15958960
• MDR Text Key: 307934489
• Report Number: 2124215-2022-47883
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2023
• Device Lot Number: 0030157559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1