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

Model Number	24700
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties requiring surgical intervention occurred.The 75% stenosed target lesion was located in a shunt in a moderately tortuous vessel.A 8.0mm x 40mm x 80cm (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure and inflated two times at 6 atmospheres, the catheter could not be pulled back into the non-boston scientific (bsc) sheath.Inflation and deflation were attempted but resistance was persisted.A small incision was then made, and the device was removed along with the non-bsc sheath.The catheter was intact on the delivery system when the device was removed from the patient no patient complications nor injuries were reported and the patient status was in good condition.
Additional Manufacturer Narrative
Correction to h6: removed impact code for delay to treatment/therapy.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 that the device returned in 3 pieces.The first piece measured approximately 30.5cm from the hub to the separated inflation and guidewire lumen.The inflation lumen of the middle piece is approximately 40cm while the guidewire lumen is approximately 60.6cm long.On the third piece the balloon is separated 40cm from the tip while the guidewire lumen is separated 10cm from the tip.There are multiple kinks along the guidewire lumen.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage what would have contributed to the difficulty to remove.H6 - impact codes: removed "delay to treatment/therapy".
Event or Problem Description
It was reported that removal difficulties requiring surgical intervention occurred.The 75% stenosed target lesion was located in a shunt in a moderately tortuous vessel.A 8.0mm x 40mm x 80cm (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure and inflated two times at 6 atmospheres, the catheter could not be pulled back into the non-boston scientific (bsc) sheath.Inflation and deflation were attempted but resistance was persisted.A small incision was then made, and the device was removed along with the non-bsc sheath.The catheter was intact on the delivery system when the device was removed from the patient no patient complications nor injuries were reported and the patient status was in good condition.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16712579
• Report Number: 2124215-2023-13278
• Device Sequence Number: 20648995
• Product Code: DQY
• UDI-Device Identifier: 08714729720690
• UDI-Public: 08714729720690
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 08/11/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025840445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: BUDDY.; GUIDEWIRE: BUDDY.; INFLATION DEVICE: ALPHA III - 30F.; INFLATION DEVICE: ALPHA III - 30F.; INTRODUCER SHEATH: VAIVT ACE 4F,; INTRODUCER SHEATH: VAIVT ACE 4F.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown