MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and non-calcified pulmonary artery.An 8.0mmx20mmx80cm (4f) and a 7.0mmx20mmx80cm (4f) sterling balloon catheters were advanced respectively for dilation.These balloons were initially inflated at 6 atmospheres for 30 seconds.However, on the second inflation at 10 atmospheres for 30 seconds, both balloons ruptured and separated vertically.The devices were removed without any problem and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
E1.Initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear 19mm from the tip and is approximately 14mm long.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and non-calcified pulmonary artery.An 8.0mmx20mmx80cm (4f) and a 7.0mmx20mmx80cm (4f) sterling balloon catheters were advanced respectively for dilation.These balloons were initially inflated at 6 atmospheres for 30 seconds.However, on the second inflation at 10 atmospheres for 30 seconds, both balloons ruptured and separated vertically.The devices were removed without any problem and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was in good condition after the procedure.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12187430
• Report Number: 2134265-2021-09195
• Device Sequence Number: 3509154
• Product Code: DQY
• UDI-Device Identifier: 08714729720645
• UDI-Public: 08714729720645
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• 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
• Report Date (Section B): 08/12/2021

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: 06/23/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025629244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1