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

Model Number	24690
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occurred.A 5.0mmx30mmx135cm (4f) sterling balloon catheter was selected for use.However, during pre-testing the balloon outside the patient's body, it was noted that the balloon could not be withdraw after inflating.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 balloon deflation failure occurred.A 5.0mmx30mmx135cm (4f) sterling balloon catheter was selected for use.However, during pre-testing the balloon outside the patient's body, it was noted that the balloon could not be withdraw after inflating.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.: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was soaked in a water bath for seven days to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device was unable to inflate.Negative pressure was then applied with the inflation device as an attempt to remove the existing contrast material present in the inflation lumen and balloon, but it was unable to deflate the device.The tact weld appeared to be out of specification, but no damage was present and the contrast in the inflation lumen made clear observation of the area difficult.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8714069
• Report Number: 2134265-2019-06356
• Device Sequence Number: 1808171
• Product Code: DQY
• UDI-Device Identifier: 08714729757122
• UDI-Public: 08714729757122
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• 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): 07/30/2019

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: 12/13/2021
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0023083261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 70