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

Model Number	24700
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occurred and removal difficulties were encountered.The target lesion was located in the iliac artery.A 6.0mm x 40mm x 135cm (4f) sterling balloon catheter was advanced for dilatation.However, during removal attempt, the balloon would not deflate.The device took 20 minutes to remove but it was removed fully inflated from the patient's body.A buddy wire was placed and the balloon and sheath was removed as one unit.The procedure was completed using alternate method or device no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter, introducer sheath and guidewire.Inspection of the device revealed that the balloon was bunched over the tip and the proximal balloon cone was bunched under the proximal end of the balloon.The outer shaft was stretched, necked down and buckled 113.5 cm from the hub extending distally toward the balloon.The guidewire was unable to be removed due to the extreme damage to the shaft.The balloon was unable to inflate or deflate as the inflation lumen/outer shaft was necked down and stretched.The sterling catheter was unable to be removed from the introducer sheath as the balloon was unable to be deflated.The introducer sheath was damaged at the distal end.
Event or Problem Description
It was reported that balloon deflation failure occurred and removal difficulties were encountered.The target lesion was located in the iliac artery.A 6.0mm x 40mm x 135cm (4f) sterling balloon catheter was advanced for dilatation.However, during removal attempt, the balloon would not deflate.The device took 20 minutes to remove but it was removed fully inflated from the patient's body.A buddy wire was placed and the balloon and sheath was removed as one unit.The procedure was completed using alternate method or device no patient complications were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 14474086
• Report Number: 2134265-2022-05237
• Device Sequence Number: 4736097
• Product Code: DQY
• UDI-Device Identifier: 08714729122784
• UDI-Public: 08714729122784
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 03/10/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0029026352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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