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

Model Number 24630

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that a proximal section of one of the blades measuring approximately 8mm was lifted on the balloon.A section of the pad was also lifted.The other blades did not exhibit any damages and were fully bonded onto the balloon.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device.Although a section of the blade was lifted, it had not detached from the balloon.An examination of the returned device identified that the balloon had been inflated.An examination of the balloon material identified a pinhole located approximately 11mm distal of the proximal markerband.An examination of the balloon material and markerbands 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

Reportable based on device analysis completed on 12jul2019.It was reported that the blade was strained bent.The 100% stenosed target lesion was located in a moderately tortuous and severely calcified iliac artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During procedure, pre dilatation was performed with a 3mm non-bsc balloon after the guidewire passed through the lesion.The balloon was then used and inflated several times at the lesion and was removed.However, it was noted that the blade was strained bent when checked after removal and there was no dislodgement occurred.Dilatation was then performed using a 7mm non-bsc balloon.The procedure was completed with this device.No complications reported and the patient was good.However, device analysis revealed balloon pinhole and blade lifted.

• 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: 8875802
• MDR Text Key: 153850310
• Report Number: 2134265-2019-09197
• 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: Physician
• Type of Report: Initial
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2020
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0022907512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• 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