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

Model Number	24700
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation failure occurred and had to be surgically removed.The target lesion was located in the superficial femoral artery bypass.A 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during procedure, the balloon failed to deflate.The physician popped the inflated balloon to proceed with device removal.However, the balloon catheter could not be removed through the 4f non- bsc sheath.The balloon catheter was surgically removed.The procedure was completed without any patient complications.
Event or Problem Description
It was reported that balloon deflation failure occurred and had to be surgically removed.The target lesion was located in the superficial femoral artery bypass.A 6.0mmx60mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during procedure, the balloon failed to deflate.The physician popped the inflated balloon to proceed with device removal.However, the balloon catheter could not be removed through the 4f non- bsc sheath.The balloon catheter was surgically removed.The procedure was completed without any patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of portions of the sterling balloon catheter, 4f cook sheath and unknown guidewire.The portion of the sterling was received in the lumen of the distal portion of the guide catheter with 5mm of the device sticking out of the tip of the guide catheter.The portion of the guidewire was received in the wire lumen of the sterling device.The sterling device was removed proximally and found that the shaft was stretched and necked down.The balloon was loosely folded with some bunching at the distal end of the balloon.The inner diameter of the guide catheter measured.059", which is consistent with a 4f sheath.The reported deflation difficulty could not be confirmed as the balloon was not inflated and could not be functionally tested.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9336705
• Report Number: 2134265-2019-13983
• Device Sequence Number: 1850101
• Product Code: DQY
• UDI-Device Identifier: 08714729123804
• UDI-Public: 08714729123804
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• 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): 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0021125385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: COOK 4F SHEATH; SHEATH: COOK 4F SHEATH; SHEATH: COOK 4F SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR