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

Model Number	24700
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture and shaft perforation occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel below the knee.A 4.0mmx100mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, during multiple times of inflation at approximately 10 atmospheres, the balloon ruptured.Additionally, a wire came out through the shaft at the balloon part.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture and shaft perforation occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel below the knee.A 4.0mmx100mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, during multiple times of inflation at approximately 10 atmospheres, the balloon ruptured.Additionally, a wire came out through the shaft at the balloon part.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
(e1) initial reporter address 1: (b)(6).Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Microscopic inspection showed a kink of the inner tube 3 cm from the tip.The hole was next to the kink and looked consistent with damage caused by a guidewire perforating the inner tube.A rupture of the balloon was not confirmed but the device did have liquid come out the distal end due to the hole of the inner tube.Device analysis determined the condition of the returned device was consistent with the reported information of a hole/perforation.

• 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: 14069262
• Report Number: 2134265-2022-03351
• Device Sequence Number: 4766117
• Product Code: DQY
• UDI-Device Identifier: 08714729123514
• UDI-Public: 08714729123514
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 04/21/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0027184838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/10/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• 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
• Patient Sex: Unknown