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

Model Number	24716
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907); Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that multiple issues had occurred in the duration of a procedure.A procedure was being performed, 95% stenosed target lesion was located in the severely calcified and mildly tortuous proximal area of the right superior femoral artery.A 6 x 200 x 90 hybrid sterling balloon catheter was being used.The physician had felt some resistance during insertion of the balloon, but it was noted that there was a lot of calcification.The balloon was able to be advanced to the targeted site.The physician inflated the balloon at nominal pressure and was described as not being well deployed.The pressure was increased to about twelve atmospheres, at which point it was said to be well deployed but that there was a "hiccup" in the proximal area.At that point, the physician believes that the balloon ruptured and broke.After the dilatation, the balloon was removed.Once it was outside the patient they saw that a part of the balloon was missing.It was attempted to remove the part from the patient by snaring, but this failed.The physician stated that the patient was okay immediately after the procedure.No pain or complications and the patient was discharged the next day.The physician said that these vessels were already in very bad condition before this procedure, that therefore this issue didn't cause any additional problems for the patient.
Additional Manufacturer Narrative
Device returned to manufacturer: returned device consisted of a sterling otw balloon catheter.The device was returned with the device packaging, and the device was bloody.The customer also supplied images of the device while the device was inflated.The balloon was shown to have an incomplete inflation/pinch/twist in the images.Analysis of the balloon, inner/outer shaft, and tack weld included microscopic and visual inspection.Inspection revealed a complete separation of the balloon material with 37mm of the balloon material left attached to the catheter, and inner shaft separation with the inner separated at the distal edge of the tack weld.The overall length of the returned device was 79.5cm, which included the hub.The tip, distal (separated) portion of the balloon and the distal portion of the inner shaft were not returned for an analysis.Inspection of the rest of the device found no other damage or defect.The reported material twist, material rupture, and detachment was confirmed.
Event or Problem Description
It was reported that multiple issues had occurred in the duration of a procedure.A procedure was being performed, 95% stenosed target lesion was located in the severely calcified and mildly tortuous proximal area of the right superior femoral artery.A 6 x 200 x 90 hybrid sterling balloon catheter was being used.The physician had felt some resistance during insertion of the balloon, but it was noted that there was a lot of calcification.The balloon was able to be advanced to the targeted site.The physician inflated the balloon at nominal pressure and was described as not being well deployed.The pressure was increased to about twelve atmospheres, at which point it was said to be well deployed but that there was a "hiccup" in the proximal area.At that point, the physician believes that the balloon ruptured and broke.After the dilatation, the balloon was removed.Once it was outside the patient they saw that a part of the balloon was missing.It was attempted to remove the part from the patient by snaring, but this failed.The physician stated that the patient was okay immediately after the procedure.No pain or complications and the patient was discharged the next day.The physician said that these vessels were already in very bad condition before this procedure, that therefore this issue didn't cause any additional problems for the patient.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10174529
• Report Number: 2134265-2020-08220
• Device Sequence Number: 2924451
• Product Code: LIT
• UDI-Device Identifier: 08714729845461
• UDI-Public: 08714729845461
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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: 04/01/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0024541622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention