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

Model Number	24700
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blood came out of the inflation port.A 2mm x 40mm x 90cm sterling balloon catheter was selected for use in an angioplasty procedure below the knee.During the procedure, the balloon was advanced as usual inside the patient and then blood came out of the inflation port.As a result, the balloon was never inflated.Another balloon was used to successfully complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that blood came out of the inflation port.A 2mm x 40mm x 90cm sterling balloon catheter was selected for use in an angioplasty procedure below the knee.During the procedure, the balloon was advanced as usual inside the patient and then blood came out of the inflation port.As a result, the balloon was never inflated.Another balloon was used to successfully complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a circumferential tear 7mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a rupture in the balloon.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11899000
• Report Number: 2134265-2021-06956
• Device Sequence Number: 3551128
• Product Code: LIT
• UDI-Device Identifier: 08714729859949
• UDI-Public: 08714729859949
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0026490654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 08/23/2021
• Patient Sequence Number: 1