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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon leak occurred.The target lesion was located in the non tortuous and calcified femoral profound artery.A 2.5mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during procedure it was noted that the balloon could not unfold normally, there was contrast leaking from the mid section of the balloon and there was blood entering the balloon.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's status was stable.
Event or Problem Description
It was reported that balloon leak occurred.The target lesion was located in the non tortuous and calcified femoral profound artery.A 2.5mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during procedure it was noted that the balloon could not unfold normally, there was contrast leaking from the mid section of the balloon and there was blood entering the balloon.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's status was stable.Device evaluated by mfr.: the device was returned for analysis.The balloon was loosely folded with blood in the balloon and inflation lumen.The tip, balloon, markerbands, proximal bond, inner shaft and outer shaft were microscopically and visually inspected.Inspection revealed a kink and inner shaft damage (puncture) located 59 cm from the tip of the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Functional test was conducted by attaching an inflation device (foiled with water) to the hub of the sterling sl device.When positive pressure was applied, the balloon could not inflate fully, and fluid was found to be leaking from the tip of the device.The reported failure to inflate and leak was confirmed.The damage to the inner shaft is consistent with a guide wire puncturing the inner shaft.

• 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: 7992161
• Report Number: 2134265-2018-62175
• Device Sequence Number: 19146206
• Product Code: DQY
• UDI-Device Identifier: 08714729782278
• UDI-Public: 08714729782278
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/05/2018

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: 03/31/2019
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0020425188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Initial Date Received by Manufacturer: 09/30/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1