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

Model Number 24700

Device Problems Material Puncture/Hole (1504); Material Rupture (1546)

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

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event 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 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.

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
• 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: 14069262
• MDR Text Key: 289073545
• Report Number: 2134265-2022-03351
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729123514
• UDI-Public: 08714729123514
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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