MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number 24700

Device Problem Deflation Problem (1149)

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

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling balloon catheter.Inspection of the device revealed that the balloon was bunched over the tip and the proximal balloon cone was bunched under the proximal end of the balloon.The outer shaft was stretched and necked down in two locations.The balloon had a puncture in the distal cone.Analysis confirmed that the damage to the catheter contributed to the deflation failure.

Event Description

It was reported that balloon deflation failure occurred.The stenosed target lesion was located in a fistula in the arm.A 8.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon would not deflate for 30 minutes.Many attempts to deflate the balloon with additional inflation devices and syringes did not work.The physician punctured the balloon with a direct stick from the outside the body through the arm graft, into the balloon.The balloon fully deflated and was removed.The procedure was completed via alternative method.No further patient complications were reported.

Manufacturer Narrative

Returned product consisted of a sterling balloon catheter.Inspection of the device revealed that the balloon was bunched over the tip and the proximal balloon cone was bunched under the proximal end of the balloon.The outer shaft was stretched and necked down in two locations.The balloon had a puncture in the distal cone.Analysis confirmed that the damage to the catheter contributed to the deflation failure.

Event Description

It was reported that balloon deflation failure occurred.The stenosed target lesion was located in a fistula in the arm.A 8.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon would not deflate for 30 minutes.Many attempts to deflate the balloon with additional inflation devices and syringes did not work.The physician punctured the balloon with a direct stick from the outside the body through the arm graft, into the balloon.The balloon fully deflated and was removed.The procedure was completed via alternative method.No further patient complications were reported.It was further reported that the final patient condition was good.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14644213
• MDR Text Key: 293842590
• Report Number: 2134265-2022-05807
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729720676
• UDI-Public: 08714729720676
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

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 Operator: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0029185805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• 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
• Patient Outcome(s): Required Intervention