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 Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely calcified and tortuous iliac artery.A 10.0 x80, 75cm charger balloon catheter was advanced for dilation.However, when the balloon was inflated at 14 atmospheres, contrast agent leakage was noted.The device was withdrawn and checked, and it was found that the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely calcified and tortuous iliac artery.A 10.0 x80, 75cm charger balloon catheter was advanced for dilation.However, when the balloon was inflated at 14 atmospheres, contrast agent leakage was noted.The device was withdrawn and checked, and it was found that the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: charger device - 10x80x75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual and microscopic examination identified a longitudinal tear in the balloon material beginning approximately at the proximal balloon bond and extending distally across the balloon material and ending approximately at the distal balloon bond.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.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 no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified damage.This type of damage is consistent with excessive force being applied to the device when attempting to cross a challenging lesion.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: 11015369
• Report Number: 2134265-2020-17615
• Device Sequence Number: 3944428
• Product Code: FGE
• UDI-Device Identifier: 08714729803812
• UDI-Public: 08714729803812
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112697
• 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): 01/14/2021

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: 06/22/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0025621954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR