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

Model Number	24681
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the 1st day of the month of the bsc aware date since event date not provided.
Event or Problem Description
It was reported that balloon deflation failure occurred.A 12.0 x60, 75cm charger balloon catheter was selected for use.However, it was noted that the balloon would not deflate.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon deflation failure occurred.A 12.0 x60, 75cm charger balloon catheter was selected for use.However, it was noted that the balloon would not deflate.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
B3 date of event: used the 1st day of the month of the bsc aware date since event date not provided.Device evaluated by mfr: charger device 12x60x75 was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure of 12 atmospheres using inflation media glycerol/water and no leaks were noted.A vacuum was then applied, and the balloon deflated fully in 30 seconds.The deflation time was verified using digital timer.The balloon was inflated to its rated burst pressure and deflated on three more occasions with no leaks noted in the device.The times were measured at 32, 35, 30 seconds.The inflation device was verified at 12 atmospheres before and after use with a calibrated pressure gauge.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no issues with the markerbands that could have contributed to the complaint incident.A visual and microscopic examination identified no issues with the tip of the device that could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage along the shaft of the device.No 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: 10319860
• Report Number: 2134265-2020-09837
• Device Sequence Number: 3178232
• Product Code: LIT
• UDI-Device Identifier: 08714729803874
• UDI-Public: 08714729803874
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/24/2020

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: 02/24/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0025258815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1