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

Model Number	24700
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation issues occurred.The target lesion was located in the superficial femoral artery.A 3.0 x 40 x 150 sterling balloon catheter was advanced for dilatation.However, it was noted that balloon would not deflate to enable removal.Subsequently, the balloon was removed by over inflation.No known patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon deflation issues occurred.The target lesion was located in the superficial femoral artery.A 3.0 x 40 x 150 sterling balloon catheter was advanced for dilatation.However, it was noted that balloon would not deflate to enable removal.Subsequently, the balloon was removed by over inflation.No known patient complications were reported and the patient's status was stable.Returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination did not reveal any damages.Microscopic examination revealed the tip is damaged.There are kinks in the guide wire lumen 13mm and 38mm from the tip.The balloon is loosely folded.The balloon was inflated to rated burst pressure and left for at least 5 minutes then it was deflated.The balloon deflated normally.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7847142
• Report Number: 2134265-2018-60716
• Device Sequence Number: 1468735
• Product Code: LIT
• UDI-Device Identifier: 08714729860136
• UDI-Public: 08714729860136
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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: 10/14/2019
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022001043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1