MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number 24634

Device Problem Deflation Problem (1149)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Patient year of birth: 2016.

Event Description

It was reported that the balloon could not be deflated and was removed surgically.A 2 cm peripheral cutting balloon was selected for use to dilate a small lung artery.After dilation of the lung artery, the balloon could not be deflated.The physician believes that he may have turned the catheter and the balloon.The patient was sent to the operating room for previously planned surgery.The balloon was successfully removed during that surgical procedure.The patient is fine post-procedure.

Event Description

It was reported that the balloon could not be deflated and was removed surgically.A 2cm peripheral cutting balloon was selected for use to dilate a small lung artery.After dilation of the lung artery, the balloon could not be deflated.The physician believes that he may have turned the catheter and the balloon.The patient was sent to the operating room for previously planned surgery.The balloon was successfully removed during that surgical procedure.The patient is fine post-procedure.

Manufacturer Narrative

Patient year of birth: 2016.Device analysis by mfr: the balloon was received without the proximal hub section of the device.The polymer extrusion shaft is completely severed approximately 5mm from the balloon bond.This type of damage is consistent with the shaft being cut with a sharp instrument.A visual examination identified that the balloon had been inflated.A high-resolution microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the blades.All blades were intact and fully bonded to the balloon surface.No issue was observed with the tip or markerbands of the device.No other issues were identified during the product analysis.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9266686
• MDR Text Key: 164653686
• Report Number: 2134265-2019-13261
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0024113055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention