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	04/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in non-severely calcified anterior tibial artery below the knee.Pre-dilation was performed with a 2.0mm sterling balloon.A 2.5mmx80mmx150cm sterling sl balloon and v18 guidewire were selected were selected for use.The balloon ruptured upon first inflation at 10 atmospheres.A 2.5mmx120mmx150cm sterling sl balloon was selected to continue the case.The 2.5mmx120mmx150cm sterling sl balloon catheter became stuck on the v18 guidewire and could not be pushed forward.Both balloon catheter and guide wire were then removed from the patient's body.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a sterling sl balloon catheter.The balloon was loosely folded, and the device was bloody.Analysis of the tip, balloon, and inner/outer shaft included microscopic and visual inspection.Inspection revealed a burst in the balloon material that was 11mm in length and located at the distal end of the balloon.Inspection of the rest of the device found no other damage or defect to the device.
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in non-severely calcified anterior tibial artery below the knee.Pre-dilation was performed with a 2.0mm sterling balloon.A 2.5mmx80mmx150cm sterling sl balloon and v18 guidewire were selected were selected for use.The balloon ruptured upon first inflation at 10 atmospheres.A 2.5mmx120mmx150cm sterling sl balloon was selected to continue the case.The 2.5mmx120mmx150cm sterling sl balloon catheter became stuck on the v18 guidewire and could not be pushed forward.Both balloon catheter and guide wire were then removed from the patient's body.The procedure was successfully completed with another sterling sl balloon and v18 guidewire.There were no patient complications reported and the patient was stable post procedure.

• 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: 10058080
• Report Number: 2134265-2020-06417
• Device Sequence Number: 3293535
• Product Code: DQY
• UDI-Device Identifier: 08714729782285
• UDI-Public: 08714729782285
• 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): 07/24/2020

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: 07/25/2021
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0024170186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1