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

Model Number	24702
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter state: (b)(6).
Event or Problem Description
It was reported that the balloon ruptured.The target lesion was highly stenosed, severely calcified and moderately tortuous.A sterling balloon was selected for a percutaneous transluminal angioplasty (pta) of the truncus tibiofibularis.The balloon was inflated to nominal pressure during the first inflation for one minute.However, the balloon ruptured and then detached.With the help of support catheters, the physician was able to remove the parts of the balloon.There were no further patient complications.The procedure was completed using a new sterling balloon.
Event or Problem Description
It was reported that the balloon ruptured.The target lesion was highly stenosed, severely calcified and moderately tortuous.A sterling balloon was selected for a percutaneous transluminal angioplasty (pta) of the truncus tibiofibularis.The balloon was inflated to nominal pressure during the first inflation for one minute.However, the balloon ruptured and then detached.With the help of support catheters, the physician was able to remove the parts of the balloon.There were no further patient complications.The procedure was completed using a new sterling balloon.
Additional Manufacturer Narrative
E1 - initial reporter state: baden-wurttemberg.Device eval by mfr: the device was returned and analysis was completed.The returned product consisted of a sterling sl balloon catheter with an unknown 0.014 guidewire and unknown introducer sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the balloon is separated.The separated distal part is pulled over the tip and measures approximately 2.6cm long.The guidewire lumen is separated 16cm from the tip and is stretched.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14355309
• Report Number: 2134265-2022-05425
• Device Sequence Number: 11798145
• Product Code: DQY
• UDI-Device Identifier: 08714729782339
• UDI-Public: 08714729782339
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/20/2023
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0028239573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male