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

Model Number	24700
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation failure and catheter removal difficulties were encountered.The target lesion was located in the straight, diffused superficial femoral artery.After a v18 guide wire and two non-bsc guide wires crossed the lesion, a 5.0mmx60mmx80cm (4f) sterling balloon catheters was advanced for pre-dilatation.The balloon was inflated at 8 atmospheres.However, after inflation, the physician was not able to deflate the balloon.The balloon was withdrawn in inflated state to the f5 11cm non-bsc guide sheath.The physician then used a biopsy needle to puncture and remove the balloon.No patient complications were reported.
Event or Problem Description
It was reported that balloon deflation failure and catheter removal difficulties were encountered.The target lesion was located in the straight, diffused superficial femoral artery.After a v18 guide wire and two non-bsc guide wires crossed the lesion, a 5.0mmx60mmx80cm (4f) sterling balloon catheters was advanced for pre-dilatation.The balloon was inflated at 8 atmospheres.However, after inflation, the physician was not able to deflate the balloon.The balloon was withdrawn in inflated state to the f5 11cm non-bsc guide sheath.The physician then used a biopsy needle to puncture and remove the balloon.No patient complications were reported.
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 contrast and blood in the balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.The outer sheath was stretched down 8.9cm from the tip for 3mm.The device was soaked in a water bath for one day to loosen the blood and contrast in the device.There was a longitudinal tear 2mm long at the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8674276
• Report Number: 2134265-2019-05773
• Device Sequence Number: 11308342
• Product Code: DQY
• UDI-Device Identifier: 08714729122944
• UDI-Public: 08714729122944
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/26/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023547950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: F5 BRITE 11CM; GUIDE CATHETER: F5 BRITE 11CM; GUIDE CATHETER: F5 BRITE 11CM
• Outcome Attributed to Adverse Event: Required Intervention