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

Model Number	24683
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used (b)(6) 2020 as event date since it event date was not provided.
Event or Problem Description
It was reported that balloon pinhole occurred.A 6.0 x200, 135cm charger balloon catheter was advanced for dilatation.However, during inflation to nominal pressure, a hole was noticed in the balloon.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
(b3) date of event: used (b)(6) 2020 as event date since it event date was not provided.
Event or Problem Description
It was reported that balloon pinhole occurred.A 6.0 x200, 135cm charger balloon catheter was advanced for dilatation.However, during inflation to nominal pressure, a hole was noticed in the balloon.The procedure was completed with a different device.No patient complications were reported.It was further reported that the 80% stenosed target lesion was located in the moderately calcified and mildly tortuous vessel.
Event or Problem Description
It was reported that balloon pinhole occurred.A 6.0 x200, 135cm charger balloon catheter was advanced for dilatation.However, during inflation to nominal pressure, a hole was noticed in the balloon.The procedure was completed with a different device.No patient complications were reported.It was further reported that the 80% stenosed target lesion was located in the moderately calcified and mildly tortuous vessel.
Additional Manufacturer Narrative
(b3) date of event: used (b)(6) 2020 as event date since it event date was not provided.Device evaluated by mfr.: a charger was returned for analysis.A red blood like substance was identified in the balloon which is indicative of a leak.The returned device was loaded onto a mandrel and attached to an encore inflation unit.Positive pressure was applied, and a pinhole leak was identified approximately 68 mm proximally from the distal markerband.A visual and microscopic examination of the balloon material identified no other issues.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified a kink at the distal end of strain relief.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.

• 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: 9967423
• Report Number: 2134265-2020-05153
• Device Sequence Number: 17102927
• Product Code: LIT
• UDI-Device Identifier: 08714729804369
• UDI-Public: 08714729804369
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2020

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: 01/27/2023
• Device Model Number: 24683
• Device Catalogue Number: 24683
• Device Lot Number: 0025114131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 04/30/2020; 06/08/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/05/2020; 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1