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

Model Number	H74939032804010
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Balloon was inflated in iliac artery, when physician tried to deflate balloon, balloon would not deflate.Several attempts were made to deflate balloon using insufflation device, physician was able to get enough air out to pass balloon through for retraction.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC STERLING PTA BALOOON DILATATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10605998
• Report Number: MW5096959
• Device Sequence Number: 2578280
• Product Code: DQY
• UDI-Device Identifier: 08714729720676
• UDI-Public: (01)08714729720676(17)230105
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/28/2020

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: 01/05/2023
• Device Model Number: H74939032804010
• Device Catalogue Number: H74939032804010
• Device Lot Number: 24990063
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2020
• 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: 53 YR
• Patient Weight: 98