MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24681
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2019 as event date since the correct date was not provided.(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x100, 135cm charger balloon catheter was advanced for dilatation.However, during inflation at 5 atmospheres, the balloon ruptured.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x100, 135cm charger balloon catheter was advanced for dilatation.However, during inflation at 5 atmospheres, the balloon ruptured.No patient complications were reported.It was further reported that the target lesion was located in the superficial femoral artery.During second inflation at 5 atmospheres for 15 seconds, the balloon ruptured.The procedure was completed with a different device and the patient's status was stable.
Additional Manufacturer Narrative
Initial reporter address: (b)(6).

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8648472
• Report Number: 2134265-2019-06014
• Device Sequence Number: 243234
• Product Code: FGE
• UDI-Device Identifier: 08714729804437
• UDI-Public: 08714729804437
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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: 03/21/2022
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0023528627
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1