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

Model Number 24700

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2023

Event Type  Injury  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 313016027
• Report Number: 2124215-2023-13278
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729720690
• UDI-Public: 08714729720690
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: BUDDY.; GUIDEWIRE: BUDDY.; INFLATION DEVICE: ALPHA III - 30F.; INFLATION DEVICE: ALPHA III - 30F.; INTRODUCER SHEATH: VAIVT ACE 4F,; INTRODUCER SHEATH: VAIVT ACE 4F.
• Patient Outcome(s): Required Intervention