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

Model Number 24716

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2019

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8369587
• MDR Text Key: 137125585
• Report Number: 2134265-2019-01583
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729845577
• UDI-Public: 08714729845577
• Combination Product (y/n): N
• PMA/PMN Number: K132430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1