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	04/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture had occurred.A percutaneous transluminal angioplasty was being performed on a 90% stenosed, severely calcified and moderately tortuous lesion below the knee.The sheath was located antegradely and the stenosis in the lower leg was explored with a v-18 controlwire guidewire.A 2.5mm x 100mm x 150cm sterling sl balloon was advanced over the v18 guidewire into the stenosis and ruptured upon inflation at 18 atmospheres.This second 2.5mm x 100mm x 150cm sterling sl balloon was used and also ruptured in the same place.The balloon ruptures were due to very hard calcification.The stenosis was resolved despite this and the patient was reported to be stable.
Additional Manufacturer Narrative
The 2.5mm x 100mm x 150cm sterling sl otw balloon catheter was returned for analysis.The balloon was loosely folded and there was blood in the balloon, inflation lumen (shaft) and wire lumen (shaft).The device was soaked in a warm water bath for 7 days.The tip, balloon, proximal weld, and inner/outer shaft were microscopically and visually inspected.Inspection revealed tip damage (bent), there was a pinhole in the balloon material located at the distal edge of the distal markerband.Inspection of the rest of the device found no other damage or irregularities.
Event or Problem Description
It was reported that a balloon rupture had occurred.A percutaneous transluminal angioplasty was being performed on a 90% stenosed, severely calcified and moderately tortuous lesion below the knee.The sheath was located antegradely and the stenosis in the lower leg was explored with a v-18 controlwire guidewire.A 2.5mm x 100mm x 150cm sterling sl balloon was advanced over the v18 guidewire into the stenosis and ruptured upon inflation at 18 atmospheres.This second 2.5mm x 100mm x 150cm sterling sl balloon was used and also ruptured in the same place.The balloon ruptures were due to very hard calcification.The stenosis was resolved despite this and the patient was reported to be 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: 8600406
• Report Number: 2134265-2019-04907
• Device Sequence Number: 2169944
• Product Code: DQY
• UDI-Device Identifier: 08714729782254
• UDI-Public: 08714729782254
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/27/2019

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: 12/27/2020
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0023120546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR