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 Code Available (3191)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified subclavian artery.A 10.0 x40, 75cm charger balloon catheter was advanced for dilatation.However, during the first inflation, the balloon ruptured.The portion of the balloon that ruptured was removed successfully with a snare.There were no patient complications reported and the patient was okay.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified subclavian artery.A 10.0 x40, 75cm charger balloon catheter was advanced for dilatation.However, during the first inflation, the balloon ruptured.The portion of the balloon that ruptured was removed successfully with a snare.There were no patient complications reported and the patent was okay.It was further reported that the lesion was 70% stenosed and mildly tortuous.The procedure was completed with a new charger balloon.
Additional Manufacturer Narrative
Describe event or problem updated.Initial reporter name and phone number updated.
Additional Manufacturer Narrative
Device evaluated by mfr: a charger 10.0 x40, 75cm was returned for analysis.The distal section of the balloon material, the tip and shaft including the markerbands and was not returned for analysis.A complete circumferential tear was identified.The balloon circumferential break was noted 3.2cm distal from the proximal bond.The distal section of balloon material was not returned.A visual and microscopic examination of the balloon material identified no further issues that could have contributed to the complaint incident.The rated burst pressure for this device is 14 atmospheres as per the print on the hub.The tip was not returned for analysis.A visual and tactile inspection identified a shaft break approximately 1cm distal from the proximal bond.Stretching and bunching on the shaft located 57cm distal to the distal end of the strain relief was also identified.The distal section of the shaft including the distal and proximal markerbands were not returned for analysis.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified subclavian artery.A 10.0 x40, 75cm charger balloon catheter was advanced for dilatation.However, during the first inflation, the balloon ruptured.The portion of the balloon that ruptured was removed successfully with a snare.There were no patient complications reported and the patent was okay.It was further reported that the lesion was 70% stenosed and mildly tortuous.The procedure was completed with a new charger balloon.

• 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: 10168365
• Report Number: 2134265-2020-08173
• Device Sequence Number: 2116296
• Product Code: FGE
• UDI-Device Identifier: 08714729803799
• UDI-Public: 08714729803799
• 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): 07/31/2020

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: 11/07/2022
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0024735061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 07/23/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/01/2020; 07/31/2020
• 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