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

Model Number	24703
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0mm x 120mm x 90cm sterling sl balloon catheter was advanced for dilatation.However, before the balloon was inflated at the nominal pressure, the balloon ruptured.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0mm x 120mm x 90cm sterling sl balloon catheter was advanced for dilatation.However, before the balloon was inflated at the nominal pressure, the balloon ruptured.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.It was further reported that the 70% stenosed target lesion was located in a shunt in a moderately tortuous and non-calcified vein.The balloon ruptured on the first inflation.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.The balloon rupture could be seen upon inspection.The rupture was 60.6 cm from the tip.Microscopic inspection showed no other damage.Blood was in the balloon.The inner tube under the balloon was wavy which could indicate stretching due to stenosis or tortuous anatomy.Device analysis determined the condition of the returned device was consistent with the reported information of a material rupture.Because there was no evidence of any product quality deficiencies, it was considered likely that the wavy inner tube was attributable to procedure issues therefore, the conclusion code "adverse event related to procedure" caused or contributed to the event.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0mm x 120mm x 90cm sterling sl balloon catheter was advanced for dilatation.However, before the balloon was inflated at the nominal pressure, the balloon ruptured.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.It was further reported that the 70% stenosed target lesion was located in a shunt in a moderately tortuous and non-calcified vein.The balloon ruptured on the first inflation.

• 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: 14022468
• Report Number: 2134265-2022-04047
• Device Sequence Number: 2631901
• Product Code: DQY
• UDI-Device Identifier: 08714729782568
• UDI-Public: 08714729782568
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2022

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: 03/19/2023
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0027002408
• 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: 03/31/2022
• Supplement Date Received by Manufacturer: 04/07/2022; 05/26/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 04/19/2022; 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown