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

Model Number 24630

Device Problem Device-Device Incompatibility (2919)

Patient Problem Blood Loss (2597)

Event Date 03/06/2020

Event Type  Injury  

Event Description

It was reported that blades of the cutting balloon cut the patient during removal.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left external iliac artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, pre dilation was performed using a 3mm-20mm and 5mm-40mm after the guidewire was crossed and then this device was used.The balloon position was slightly shifted at 6atm for about 30 seconds on the first time, and the vessel was dilated three times at about 6atm to 8atm for about 30 seconds.Inflation and deflation were performed slowly, however the blade protruded from the sheath upon removal and bleeding was noted.As per physician, the blade cut the skin at the puncture sit which made the site expanded.The procedure was completed with a different device.There were no patient complications reported.

Event Description

It was reported that blades of the cutting balloon cut the patient during removal.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left external iliac artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, pre dilation was performed usin a 3mm-20mm and 5mm-40mm afte the guidewire was crossed and then this devcie was used.The balloon position was slightly shifted at 6atm for about 30 seconds on the first time, and the vessel was dilated three times at about 6atm to 8atm for about 30 seconds.Inflation and deflation were performed slowly, however the blade protruded from the sheath upon removal and bleeding was noted.As per physician, the blade cut the skin at the puncture sit which made the site expanded.The procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The returned device was received together with customers introducer sheath.The customers sheath was torn along its entire length.As the customers sheath was torn the investigator choose a new 6fr introducer sheath for investigation purposes.On analysis, the investigator applied a vacuum and successfully advanced the device through a 6fr boston scientific introducer sheath and successfully withdrew the device without any resistance issues or damage to the sheath noted.No issues were noted that could have contributed to the complaint incident.All blades were present and fully bonded to the surface of the balloon.No issues were noted that may have potentially contributed to the complaint incident.The balloon was unfolded which indicates it had been subjected to positive pressure.No issues were identified with the balloon material that may have contributed to the complaint incident.No issue was observed with the tip or markerbands of the device.A visual and tactile examination found no damage or kinks on the shaft the device.No other issues were identified during the product analysis.

Event Description

It was reported that blades of the cutting balloon cut the patient during removal.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified left external iliac artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, pre dilation was performed using a 3mm-20mm and 5mm-40mm after the guidewire was crossed and then this device was used.The balloon position was slightly shifted at 6atm for about 30 seconds on the first time, and the vessel was dilated three times at about 6atm to 8atm for about 30 seconds.Inflation and deflation were performed slowly, however the blade protruded from the sheath upon removal and bleeding was noted.As per physician, the blade cut the skin at the puncture site which made the site expanded.The procedure was completed with a different device.There were no patient complications reported.It was further reported that there was no visual damage on the balloon.The balloon was removed as performing hemostasis treatment due to bleeding.Subsequently, it was about 200 cc or less with no blood transfusion was performed.The blood was accumulated in the drape on the patient.Then, there was no remnant left in the body.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.The returned device was received together with customers introducer sheath.The customers sheath was torn along its entire length.As the customers sheath was torn the investigator choose a new 6fr introducer sheath for investigation purposes.On analysis, the investigator applied a vacuum and successfully advanced the device through a 6fr boston scientific introducer sheath and successfully withdrew the device without any resistance issues or damage to the sheath noted.No issues were noted that could have contributed to the complaint incident.All blades were present and fully bonded to the surface of the balloon.No issues were noted that may have potentially contributed to the complaint incident.The balloon was unfolded which indicates it had been subjected to positive pressure.No issues were identified with the balloon material that may have contributed to the complaint incident.No issue was observed with the tip or markerbands of the device.A visual and tactile examination found no damage or kinks on the shaft 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: 9888381
• MDR Text Key: 187708376
• Report Number: 2134265-2020-03967
• 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,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2021
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0024476257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH- 6FR 25CM TERUMO; SHEATH- 6FR 25CM TERUMO; SHEATH- 6FR 25CM TERUMO
• Patient Outcome(s): Required Intervention