MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24716
Medical Device Problem Codes	Deflation Problem (1149); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation difficulties occurred.The target lesion was located in a vessel in the left leg.A 6.0x220x150 sterling balloon catheter was advanced for dilatation.The contrast agent used was omni 300 with a contrast ratio of 50/50 with saline.However, during inflation at 14 atmospheres for 30 seconds, the balloon did not inflate properly and appeared to be deformed.Balloon deflation difficulties were encountered but eventually the balloon was removed fully deflated.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter with an introducer sheath.Microscopic examination revealed no damage.A test inflation device was connected to the hub and pressurized inflating the device to rated burst pressure.The device maintained pressure for 5 minutes with no leaks or irregularities.The device was then successfully deflated with no issues.
Event or Problem Description
It was reported that balloon deflation difficulties occurred.The taget lesion was located in a vessel in the left leg.A 6.0x220x150 sterling balloon catheter was advanced for dilatation.The contrast agent used was omni 300 with a contrast ratio of 50/50 with saline.However, during inflation at 14 atmospheres for 30 seconds, the balloon did not inflate properly and appeared to be deformed.Balloon deflation difficulties were encountered but eventually the balloon was removed fully deflated.The procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9538847
• Report Number: 2134265-2019-16086
• Device Sequence Number: 2375265
• Product Code: LIT
• UDI-Device Identifier: 08714729845485
• UDI-Public: 08714729845485
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• 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): 02/06/2020

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: 04/21/2020
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0022839512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR