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

Model Number 24658

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Failure to Deflate (4060)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

It was reported that it was difficult to remove the device.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right superficial femoral artery.A 4.00mm x 1.5cm x 140cm small peripheral cutting balloon was selected for use.During procedure, the device was used to inflate upon first inflation at 6 atmospheres within 30 seconds.However, it was noted that the device could not be inserted into the introducer sheath, and it could not be removed.The possibility of deflation was also considered; therefore, another removal was attempted after deflation, however, it got stuck in the introducer sheath and could not be recovered.Finally, the balloon was removed with the introducer sheath using the normal method after dilatation.All guidewires and devices were removed from the patient's body and the procedure was completed with a different device.Per physician's comment, it was unlikely that it would get stuck, and it was possible that the balloon lumen was flattened and could not be deflated properly.No complications reported and there was no patient injury.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The investigator was unable to inflate or deflate the balloon due to the damaged shaft.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination identified that the inner, outer polymer extrusion was stretched.This concludes the product analysis.

Event Description

It was reported that it was difficult to remove the device.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right superficial femoral artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During procedure, the device was used to inflate upon first inflation at 6 atmospheres within 30 seconds.However, it was noted that the device could not be inserted into the introducer sheath, and it could not be removed.The possibility of deflation was also considered; therefore, another removal was attempted after deflation, however, it got stuck in the introducer sheath and could not be recovered.Finally, the balloon was removed with the introducer sheath using the normal method after dilatation.All guidewires and devices were removed from the patient's body and the procedure was completed with a different device.Per physician's comment, it was unlikely that it would get stuck, and it was possible that the balloon lumen was flattened and could not be deflated properly.No complications reported and there was no patient injury.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15958697
• MDR Text Key: 305354239
• Report Number: 2124215-2022-51955
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2023
• Device Model Number: 24658
• Device Catalogue Number: 24658
• Device Lot Number: 0026237601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1