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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Event date is not known.The aware date for this complaint was (b)(4) 2018.Therefore, a date of (b)(6) 2018 was entered in the required event date field, which indicates that the event occurred on an unknown day in october 2018.
Event or Problem Description
It was reported that a balloon burst occurred.The more than 50% stenosed target lesion was located in the superficial femoral artery.A 4.0mm x 100mm x 135 cm (4f) sterling balloon was used to dilate the target lesion and after some seconds at 3 atmospheres, the balloon burst.The balloon was deflated and removed.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was okay.
Additional Manufacturer Narrative
Date of birth: year provided (b)(6).Date of event was estimated on the initial report, additional information received indicated the event date of (b)(6) 2018.
Event or Problem Description
It was reported that a balloon burst occurred.The more than 50% stenosed target lesion was located in the superficial femoral artery.A 4.0mm x 100mm x 135 cm (4f) sterling balloon was used to dilate the target lesion and after some seconds at 3 atmospheres, the balloon burst.The balloon was deflated and removed.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was okay.Device evaluated by mfr: returned device consisted of a maverick 2 balloon catheter.The balloon was loosely folded and there was blood in the balloon, inflation lumen and wire lumen.The tip, balloon, markerbands, inner/outer shaft and hypotube were microscopically and visually inspected.Inspection revealed a pinhole in the balloon material that was 5 mm distal from the proximal markerband.Device analysis determined the condition of the returned device was consistent with the reported information.Functional testing was conducted by attaching an inflation device (filled with water) to the hub of the sterling catheter.When positive pressure was applied, fluid was found to be streaming from the balloon.The reported rupture was confirmed.
Additional Manufacturer Narrative
Corrections made to device type identified within analysis results from maverick 2 to sterling otw.Corrections from adverse event related to procedure to adverse event related to patient condition.Date of birth: year provided 1927.Date of event was estimated on the initial report, additional information received indicated the event date of (b)(6) 2018.
Event or Problem Description
It was reported that a balloon burst occurred.The more than 50% stenosed target lesion was located in the superficial femoral artery.A 4.0mm x 100mm x 135 cm (4f) sterling balloon was used to dilate the target lesion and after some seconds at 3 atmospheres, the balloon burst.The balloon was deflated and removed.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was okay.Device evaluated by mfr: returned device consisted of a sterling otw balloon catheter.The balloon was loosely folded and there was blood in the balloon, inflation lumen and wire lumen.The tip, balloon, markerbands, inner/outer shaft and hypotube were microscopically and visually inspected.Inspection revealed a pinhole in the balloon material that was 5 mm distal from the proximal markerband.Device analysis determined the condition of the returned device was consistent with the reported information.Functional testing was conducted by attaching an inflation device (filled with water) to the hub of the sterling catheter.When positive pressure was applied, fluid was found to be streaming from the balloon.The reported rupture was confirmed.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8009333
• Report Number: 2134265-2018-62313
• Device Sequence Number: 13508283
• Product Code: DQY
• UDI-Device Identifier: 08714729123507
• UDI-Public: 08714729123507
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 02/04/2019

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: 08/05/2021
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0022473173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/30/2018; 01/14/2019
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 11/21/2018; 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1