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

Model Number	24702
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
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 balloon rupture occurred.During a left popliteal artery dilatation, a 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced.However, on initial inflation at 10 atmospheres, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The balloon was loose and there was blood and dried contrast in the inflation lumen (shaft).The tip, balloon, markerbands, proximal weld, and inner/outer shaft were microscopically and visually inspected.Inspection revealed a burst in the balloon material that was 11 mm in length.Inspection of the remainder of the device found no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.During a left popliteal artery dilatation, a 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced.However, on initial inflation at 10 atmospheres, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported.

• 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: 8182374
• Report Number: 2134265-2018-64316
• Device Sequence Number: 1587923
• Product Code: DQY
• UDI-Device Identifier: 08714729782292
• UDI-Public: 08714729782292
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2019

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: 08/02/2020
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0022464275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR