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

Model Number	24690
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment occurred.A 7.0mmx30mmx135cm 4 french sterling balloon catheter was advanced for treatment.Vascular access was gained via the right femoral artery.Angiogram was performed in the left internal iliac artery.There was no abnormality found when the balloon was inflated.The physician released the pressure in the balloon and withdrew the balloon to adjust the position.It was found the balloon could not move.The physician exerted force and the balloon could slightly move.The physician exerted force again; however, the balloon could not move but the delivery shaft could be withdrawn.The delivery shaft was removed from the patient; however, the balloon was left in left internal iliac artery.Surgery occurred retrieve the balloon.There were no patient complications reported.
Event or Problem Description
It was reported that balloon detachment occurred.A 7.0mmx30mmx135cm 4 french sterling balloon catheter was advanced for treatment.Vascular access was gained via the right femoral artery.Angiogram was performed in the left internal iliac artery.There was no abnormality found when the balloon was inflated.The physician released the pressure in the balloon and withdrew the balloon to adjust the position.It was found the balloon could not move.The physician exerted force and the balloon could slightly move.The physician exerted force again; however, the balloon could not move but the delivery shaft could be withdrawn.The delivery shaft was removed from the patient; however, the balloon was left in left internal iliac artery.Surgery occurred retrieve the balloon.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 106cm distal of the strain relief.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9860527
• Report Number: 2134265-2020-03631
• Device Sequence Number: 17002326
• Product Code: DQY
• UDI-Device Identifier: 08714729757566
• UDI-Public: 08714729757566
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: 06/11/2021
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0022241009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2020
• Initial Date Received by Manufacturer: 03/15/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/22/2020
• 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
• Patient Age: 35 YR
• Patient Weight: 60