MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CHARGER PTA BALLOON DILATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number UNK721

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr:: the device was not received for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

(b)(6) study.It was reported that an immediate recoil in the vessel post angioplasty occurred.In (b)(6) 2016, clinical status assessment identified the patient¿s qualifying conditions as rutherford category 3.Seven days later, the index procedure was performed.The target lesion was located in the right leg mid superficial femoral artery (sfa) with 100% stenosis and was 100mm long with proximal reference vessel diameter of 5.4mm and distal vessel diameter of 5.9mm and was classified as tasc ii a lesion.The target lesion was treated initially by angioplasty using a 6.00 x 100mm charger balloon catheter; however, post angioplasty, there was an area of recoil noted in the mid sfa.Subsequently, a 6.0 x 100mm non-bsc study stent was deployed, followed by post dilatation with residual stenosis of 10% and the procedure was completed.

• Brand Name: CHARGER PTA BALLOON DILATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6648626
• MDR Text Key: 77821330
• Report Number: 2134265-2017-05884
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR