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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 2.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured and so insufflation was not possible.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 2.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured and so insufflation was not possible.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the approximately 40% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel.On the first balloon inflation, the contrast "escaped".The balloon was inflated a second time at 12 atmospheres for 20 seconds which the contrast did not completely fill the balloon.The device was removed and tested outside the patient and the hole in the balloon was noted.The patient's status post procedure was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of a sterling sl balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a leak on the manifold from one of the two adhesive injection ports.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.A 2.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured and so insufflation was not possible.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the approximately 40% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel.On the first balloon inflation, the contrast "escaped".The balloon was inflated a second time at 12 atmospheres for 20 seconds which the contrast did not completely fill the balloon.The device was removed and tested outside the patient and the hole in the balloon was noted.The patient's status post procedure was stable.

• 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: 10239721
• Report Number: 2134265-2020-08975
• Device Sequence Number: 11370887
• Product Code: DQY
• UDI-Device Identifier: 08714729782230
• UDI-Public: 08714729782230
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2021

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: 07/17/2021
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0024126651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/21/2020; 02/12/2021
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/29/2020; 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1