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

Model Number	24703
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the deep vein of the lower limb.A 3.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilation.However, resistance at the tip of the balloon was encountered.The device could not move and could not reach the lesion.The physician attempted to remove the balloon but the balloon lumen and the guide wire were stuck and could not be removed.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the deep vein of the lower limb.A 3.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilation.However, resistance at the tip of the balloon was encountered.The device could not move and could not reach the lesion.The physician attempted to remove the balloon but the balloon lumen and the guide wire were stuck and could not be removed.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.It was further reported that both devices were eventually removed together.
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.The balloon was loosely folded.Microscopic inspection revealed tip damage.The outer shaft was buckled at the strain relief.The inner shaft was buckled at numerous sections in the shaft, as well as throughout the entire balloon.The guidewire was stuck in the device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the deep vein of the lower limb.A 3.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilation.However, resistance at the tip of the balloon was encountered.The device could not move and could not reach the lesion.The physician attempted to remove the balloon but the balloon lumen and the guide wire were stuck and could not be removed.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.It was further reported that both devices were eventually removed together.

• 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: 8576171
• Report Number: 2134265-2019-04808
• Device Sequence Number: 2039231
• Product Code: DQY
• UDI-Device Identifier: 08714729782308
• UDI-Public: 08714729782308
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2019

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: 08/10/2020
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0022501224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019; 07/25/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/06/2019; 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 65