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

Model Number	24700
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture, catheter removal difficulty, and shaft break occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified subclavian artery.An 8.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, on initial inflation at 12 atmospheres for 10 seconds, the balloon ruptured.The physician stated that the balloon was slippery in the lesion, so the physician inflated the balloon with pulling tension.When the balloon was removed, it became stuck.When it was pulled, the shaft got separated about 60cm from the hub.All device fragments that remained inside the body were retrieved through operation.The procedure was not completed due to this event.No further patient complications were reported.
Event or Problem Description
It was reported that balloon rupture, catheter removal difficulty, and shaft break occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified subclavian artery.An 8.0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, on initial inflation at 12 atmospheres for 10 seconds, the balloon ruptured.The physician stated that the balloon was slippery in the lesion, so the physician inflated the balloon with pulling tension.When the balloon was removed, it became stuck.When it was pulled, the shaft got separated about 60cm from the hub.All device fragments that remained inside the body were retrieved through operation.The procedure was not completed due to this event.No further patient complications were reported.
Additional Manufacturer Narrative
(e1) initial reporter address 1: (b)(6).(e1) initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a sterling balloon catheter with a guidewire in the lumen.Visual and microscopic inspection revealed that the balloon had a complete circumferential tear and the inner shaft was stretched and separated at the bi-compontent weld.The shaft separation was consistent with tensile overload.The distal end of the balloon was bunched over the tip, which indicates force during removal of the device.The guidewire was stuck in the balloon catheter due to the stretched shaft.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10801048
• Report Number: 2134265-2020-15281
• Device Sequence Number: 3266949
• Product Code: DQY
• UDI-Device Identifier: 08714729720690
• UDI-Public: 08714729720690
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 01/21/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025081224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention