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

Model Number	24716
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft perforation occurred.The target lesion was located in the left superficial femoral artery.After insertion of a non-bsc guide wire, a 4.0x220x90 (4f) sterling balloon catheter was advanced for dilation.However, during imaging, the wire appeared to be coming out of the device.The device was removed and was inflated outside of the patient.It was then noted that the catheter had three holes.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.
Event or Problem Description
It was reported that shaft perforation occurred.The target lesion was located in the left superficial femoral artery.After insertion of a non-bsc guide wire, a 4.0x220x90 (4f) sterling balloon catheter was advanced for dilation.However, during imaging, the wire appeared to be coming out of the device.The device was removed and was inflated outside of the patient.It was then noted that the catheter had three holes.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: received product consisted of a sterling otw balloon catheter.The balloon was loosely folded with blood in the balloon and the inflation lumen (shaft).The tip, balloon, inner/outer shaft and port/exit notch were microscopically and visually inspected.Inspection revealed pinholes in the balloon material located 5cm, 10cm, and 12cm from the tip of the device.Inspection of the rest of the device found no other damage or irregularities.The sterling device was attached to an inflation device (filled with water), and when positive pressure was applied, the device leaked from the pinholes.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8545118
• Report Number: 2134265-2019-04253
• Device Sequence Number: 19443808
• Product Code: LIT
• UDI-Device Identifier: 08714729860327
• UDI-Public: 08714729860327
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: 12/05/2019
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0022227531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1