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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date as no information was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x20, 135cm charger balloon catheter was advanced for dilatation.However, the balloon burst before reaching the maximum burst pressure.There were no patient complications reported.
Additional Manufacturer Narrative
B3 - date of event: used the first day of the month of the bsc aware date as no information was provided.Device evaluated by mfr.: charger 6.0 x20, 135cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 18 atmospheres for 30 seconds using digital timer: g24610, without issue.A vacuum was then applied.The inflation device was verified at 18 atmospheres, before and after use with calibrated pressure gauge g19252.This inflation to rate of burst pressure of 18 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from kinks or damage.D4 updated based on the product returned.1.Lot number updated from unknown to 27857725.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x20, 135cm charger balloon catheter was advanced for dilatation.However, the balloon burst before reaching the maximum burst pressure.There were no patient complications reported.It was further reported that the balloon ruptured during initial inflation.The device was removed intact, and the procedure was completed with another balloon.The patient condition was good post-procedure.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16569006
• Report Number: 2124215-2023-12671
• Device Sequence Number: 17676891
• Product Code: FGE
• UDI-Device Identifier: 08714729804345
• UDI-Public: 08714729804345
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 08/17/2024
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0027857725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown