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

Model Number	24716
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft perforation occurred.The target lesion was located in a vessel in a lower extremity.A 7.0x220x90mm sterling balloon catheter was selected for use.However, when the device was advanced over the wire, the wire somehow perforated the side lumen of the device.The procedure was completed with another of the same device.There were no patient complications reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned device consisted of a sterling otw balloon catheter.The balloon was loosely folded with blood in the wire lumen (shaft).There was dried contrast in the balloon and inflation lumen.The tip, balloon, markerbands, proximal weld, inner/outer shaft (lumen) were microscopically and visually inspected.Inspection revealed a perforation in the inner lumen(shaft) located 61mm from the tip, inner lumen damage (buckle) located 59-31mm from the tip, and tip damage (smashed).Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The wire used in the procedure was not returned for functional testing, so a lab supplied.014 inch guide wire was used to test the device.When the device was first tested, the wire could load into the sterling, but was sticky, do the complaint device was soaked in a warm waterbath for 10 minutes, then removed, and retested.The wire was loaded into the tip of the device and advanced for approximately 61mm, then stopped.When the wire was loaded into the wire port of the manifold and advanced, the wire advanced until the inner lumen/shaft damage and protruded out through a hole in the lumen material, 61mm from tip.The functional testing was able to be done after soaking and removing the blood from the wire lumen.
Event or Problem Description
It was reported that shaft perforation occurred.The target lesion was located in a vessel in a lower extremity.A 7.0x220x90mm sterling balloon catheter was selected for use.However, when the device was advanced over the wire, the wire somehow perforated the side lumen of the device.The procedure was completed with another of the same device.There were no patient complications reported and the patient was fine.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8369587
• Report Number: 2134265-2019-01583
• Device Sequence Number: 1620891
• Product Code: LIT
• UDI-Device Identifier: 08714729845577
• UDI-Public: 08714729845577
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• 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): 04/05/2019

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: 04/22/2020
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 22846731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1