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

Model Number	24703
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon leak occurred.The target lesion was located in the straight last third of superficial femoral artery (sfa) and proximal popliteal artery, it was soft and was 140mm long.A 4.0mm x 150mm x 150cm sterling sl was selected for dilatation.However, during inflation at 8 atmospheres, the pressure in the insufflator was descending at 1/2 atmospheres per 2 seconds.The balloon was also losing pressure, it was noted under fluoroscopy.The physician induced again pressure until it reach 8 atmospheres but noted that the contrast media was going out through the wire port of the balloon hub.The pressure was going down again at 1/2 atmospheres per 2 seconds and the balloon was losing its diameter.The device was removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that balloon leak occurred.The target lesion was located in the straight last third of superficial femoral artery (sfa) and proximal popliteal artery, it was soft and was 140mm long.A 4.0mm x 150mm x 150cm sterling sl was selected for dilatation.However, during inflation at 8 atmospheres the pressure in the insufflator was descending at 1/2 atmospheres per 2 seconds.The balloon was also losing pressure, it was noted under fluoroscopy.The physician induced again pressure until it reach 8 atmospheres but noted that the contrast media was going out through the wire port of the balloon hub.The pressure was going down again at 1/2 atmospheres per 2 seconds and the balloon was losing its diameter.The device was removed from the patient's body.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.Device evaluated by mfr.: the inner/outer shaft, balloon and tip were microscopically and visually inspected.Inspection revealed numerous kinks in the inner shaft, tip damage (flared), and inner shaft damage (puncture) located 87 mm from the tip.The inner damage (puncture) is consistent with a guide wire puncturing the inner shaft material, and the tip damage is consistent with guide wire use.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Functional testing was conducted by attaching an inflation device (filled with water) to the hub of the sterling sl hub, and when positive pressure was applied, water leaked out from the tip and hub of the device.Device analysis determined the condition of the returned device was consistent with the reported information.The reported balloon leak and failure to inflate was confirmed.The damage to the device is consistent with a device being used in challenging anatomy.

• 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: 8015653
• Report Number: 2134265-2018-62380
• Device Sequence Number: 1369213
• Product Code: DQY
• UDI-Device Identifier: 08714729782384
• UDI-Public: 08714729782384
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 12/11/2018

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: 03/21/2020
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0021895973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 55