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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occured.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A 3.0mm x 80mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during initial inflation at 4 atmospheres, the balloon ruptured.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 rupture occured.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A 3.0mm x 80mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during initial inflation at 4 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.(d4) lot number updated from 0025404085 to 0025118611.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A 3.0mm x 80mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during initial inflation at 4 atmospheres, the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.(d4) lot number updated from 0025404085 to 0025118611.Device evaluated by mfr.: returned product consisted of a sterling sl catheter.The balloon was loosely folded and there was blood in the balloon and shaft.Analysis of the tip, balloon, inner/outer shaft and hub/strain relief included microscopic and visual inspection.Inspection revealed a pinhole in the balloon material located 28mm from the tip of the device.Inspection of the rest of the device found no other damage or defect.Review of the product specification indicates the rated burst pressure of the complaint device is 14atm.The reported information indicates the device was inflated to 4atm; therefore, there is no indication the device was inflated over rbp.The reported balloon burst was confirmed.

• 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: 10959319
• Report Number: 2134265-2020-17080
• Device Sequence Number: 3189013
• Product Code: DQY
• UDI-Device Identifier: 08714729782322
• UDI-Public: 08714729782322
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2021

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: 01/27/2022
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0025118611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 01/13/2021; 02/08/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 01/19/2021; 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1