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

Model Number	24702
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation issue occurred.The 30% stenosed target lesion was located in the non-tortuous and non-calcified tibial artery.A 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for pre-dilatation.The balloon was inflated at 6 atmospheres for 60 seconds with 50% contrast ratio.However, the balloon deflated rather slowly after inflation.It took a few deflation cycles before the balloon was deflated flat enough for removal.The device was completely removed and the procedure was completed with another of the same device.No patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The outer shaft was stretched down 5mm starting at the proximal end of the balloon and extending proximally, this would have caused issues with deflating the balloon.The inner shaft was buckled in the balloon for 20mm starting at the proximal end of the balloon.The device was functionally tested with an inflation device.The balloon was unable to inflate.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon deflation issue occurred.The 30% stenosed target lesion was located in the non-tortuous and non-calcified tibial artery.A 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for pre-dilatation.The balloon was inflated at 6 atmospheres for 60 seconds with 50% contrast ratio.However, the balloon deflated rather slowly after inflation.It took a few deflation cycles before the balloon was deflated flat enough for removal.The device was completely removed and the procedure was completed with another of the same device.No patient complications reported and the patient's status was stable.

• 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: 8793748
• Report Number: 2134265-2019-08184
• Device Sequence Number: 1832519
• Product Code: DQY
• UDI-Device Identifier: 08714729782292
• UDI-Public: 08714729782292
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Followup
• Report Date (Section B): 08/22/2019

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: 10/16/2020
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0022807800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1