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

Model Number	24681
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a balloon longitudinal tear beginning approximately 19mm proximal of the proximal markerband and extending approximately 83mm distally across the balloon material.Inflation of the device is not possible due to the tear on the balloon material.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no issues with the tip which could possibly have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 10jan2019.It was reported that failure to inflate occured.The 90% stenosed target lesion located in the severely tortuous and severely calcified illiac vein (left lower limb).A 12.0 x80, 75cm charger was used to deliver.However, balloon could not dilate after 5 seconds at 10 atmosphere.The physician completed the procedure by retrieving the device and by using another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed balloon longitudinal tear.

• 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: 8285104
• Report Number: 2134265-2019-00500
• Device Sequence Number: 19320993
• Product Code: FGE
• UDI-Device Identifier: 08714729803881
• UDI-Public: 08714729803881
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0022457958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/29/2019
• Patient Sequence Number: 1
• Patient Age: 63 YR