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

Model Number	24700
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2134265-2022-05807
• Device Sequence Number: 4841786
• Product Code: DQY
• UDI-Device Identifier: 08714729720676
• UDI-Public: 08714729720676
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2025
• 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown