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

Model Number 24628

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Event Description

It was reported that the blade was lifted.A 2cm peripheral cutting balloon (pcb) was used in a shunt percutaneous transluminal angioplasty (pta) procedure.During procedure, after performing balloon dilation at nominal pressure for three times, the balloon was removed from the sheath.Subsequently, it was noted that the blade became lifted from the balloon.The device was then simply puled out from the patient's body and it was confirmed that the balloon did not detach from the balloon.No complications were reported and the patient's condition post procedure was good.

Manufacturer Narrative

Device evaluated by mfr: the device was retuned for analysis.The device was received together with the customers 6fr introducer sheath.The recommended introducer sheath size for this device is a 6f as per 2cm peripheral cutting balloon dfu.The customers sheath was returned for analysis.The customers sheath was split distally from its tip for approximately 20mm.This type of damage is consistent with a blade of the returned device catching on the sheath during withdrawal.A visual and microscopic examination was performed on the returned device.It was noted that a section of one of the blades measuring approximately 10mm was lifted distally from its blade pad.The entire blade pad remained undamaged and fully bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device.All other blades were intact and fully bonded to the balloon material.An examination of the returned device identified that the balloon had been inflated.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.

Event Description

It was reported that the blade was lifted.A 2cm peripheral cutting balloon (pcb) was used in a shunt percutaneous transluminal angioplasty (pta) procedure.During procedure, after performing balloon dilation at nominal pressure for three times, the balloon was removed from the sheath.Subsequently, it was noted that the blade became lifted from the balloon.The device was then simply pulled out from the patient's body and it was confirmed that the balloon did not detach from the balloon.No complications were reported and the patient's condition post procedure was good.

• 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: 8374076
• MDR Text Key: 137273709
• Report Number: 2134265-2019-01732
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: 24628
• Device Catalogue Number: 24628
• Device Lot Number: 0022937041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRODUCER SHEATH- GP6F3CM; INTRODUCER SHEATH- GP6F3CM; INTRODUCER SHEATH- GP6F3CM