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

Model Number	24703
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event : 18 years or older.
Event or Problem Description
It was reported that the balloon could not deflate.A 4.00mmx120mmx150cm sterling sl balloon was selected for use in a procedure in the iliac.After the balloon was inflated, it could not be deflated.Negative pressure was attempted several times but the balloon would not entirely deflate.The balloon extended from the proximal portion when it was removed.The procedure was completed with a new balloon of the same model.There were no patient complications reported.The patient condition post-procedure was good.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9990670
• Report Number: 2134265-2020-05456
• Device Sequence Number: 19792265
• Product Code: DQY
• UDI-Device Identifier: 08714729782377
• UDI-Public: 08714729782377
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K093720
• 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
• Report Date (Section B): 04/23/2020

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: 10/26/2020
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0022854139
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1