MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 24658

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).

Event Description

It was reported that the balloon was damaged.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, after opening the device and upon checking the balloon part, it was observed that the proximal part of the balloon was discolored black.The appearance was black and seems burnt.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

E1 - initial reporter address:(b)(6).Device evaluated by mfr: spcb flextome mr- 4.00mm/1.5cm/140cm-ous was received for analysis.An examination of the returned device identified that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.The tip, balloon and markerbands of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.A visual and microscopic examination observed no damage to the blades.All blades were present and fully bonded to the balloon surface.Oxidation of the blades was noted.This is attributed to the blades being exposed to moisture which oxidizes the blades over a period.The device was received inside its protective hoop.Brown oxidation was noted inside the protective hoop which is an indication that the device was exposed to moisture before being placed inside the hoop.No kinks or damage were noted along the shaft of the device.This concludes the product analysis.

Event Description

It was reported that the balloon was damaged.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, after opening the device and upon checking the balloon part, it was observed that the proximal part of the balloon was discolored black.The appearance was black and seems burnt.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12523977
• MDR Text Key: 273107241
• Report Number: 2134265-2021-11988
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• 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: 10/28/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0025995231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1