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

Model Number 24630

Device Problems Failure to Advance (2524); Device Damaged by Another Device (2915)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that there was bleeding and slit on sheath. Vascular access was obtained via ipsilateral approach. The 95% stenosed target lesion was located in the moderately calcified popliteal artery. A 6. 00mm/ 2. 0cm/ 90cm peripheral cutting balloon was selected for use. During procedure, the device was advanced after a guidewire passed through. However, the device had difficulty in crossing the lesion thus pre-dilation was performed with cob. The device was delivered again and dilatation was performed repeatedly for several times. Subsequently, bleeding was observed in the subcutaneous femoral when the sheath was removed. The blade of the balloon slit the sheath over its entire length in one direction causing the blood leaked. The bleeding was arrested by astriction. Per physician's opinion, the bleeding was caused by the balloon blade. The procedure was completed with this device. No further complications reported and patient was stable post procedure.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10437043
• MDR Text Key: 203991784
• Report Number: 2134265-2020-11436
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/13/2022
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0025510578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/21/2020 Patient Sequence Number: 1