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

Model Number	24683
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the superficial femoral artery.A 5.0 x200, 135cm charger balloon catheter was advanced for dilation.It was noted that the balloon was held at nominal atmospheres for one minute during inflation.However, after successful inflation, the balloon failed to deflate.The physician tried to use different syringes to draw out solution and were able to get down enough to pull it out of the sheath.The device was removed fully intact and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the superficial femoral artery.A 5.0 x200, 135cm charger balloon catheter was advanced for dilation.It was noted that the balloon was held at nominal atmospheres for one minute during inflation.However, after successful inflation, the balloon failed to deflate.The physician tried to use different syringes to draw out solution and were able to get down enough to pull it out of the sheath.The device was removed fully intact and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Corrected batch/lot number from 25954152 to 26054270.Device evaluated by mfr: a charger device 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 using inflation media glycerol/water and no leaks were noted.A vacuum was then applied, and the balloon deflated fully in 54 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 52, 47, 46 seconds.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.

• 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: 10885275
• Report Number: 2134265-2020-16230
• Device Sequence Number: 16843945
• Product Code: FGE
• UDI-Device Identifier: 08714729804222
• UDI-Public: 08714729804222
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 12/23/2020

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: 09/21/2023
• Device Model Number: 24683
• Device Catalogue Number: 24683
• Device Lot Number: 0026054270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR