MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CHARGER¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939206081010

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

Patient Problems Perforation of Vessels (2135); Diminished Pulse Pressure (2606)

Event Date 02/17/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr. : it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

Event Description

It was reported that a vessel perforation occurred. The target lesion was located in the left iliac artery. An 8x100 innova stent was implanted in the vessel. Post-dilation of the stent was performed with an 8. 0x100, 135cm charger¿ balloon catheter and "it looked great. " it was then decided to dilate the lesion proximal to the stent where there was some plaque and a vessel perforation occurred. The patient's pressures started to drop, however the balloon was reinflated and the patient's status improved. A 7x50 non-bsc stent was then advanced to cover the perforation. Post-dilation was performed and the perforation was completely covered. The patient's pressures immediately started to rise. The patient was kept for observation and was doing "really well. " the following day the patient was considered completely recovered and was discharged.

• Brand Name: CHARGER¿
• 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: 6393748
• MDR Text Key: 69555801
• Report Number: 2134265-2017-01897
• 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

• Type of Report: Initial
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: H74939206081010
• Device Catalogue Number: 3920608101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/17/2017
• 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 Treatment Data

Date Received: 03/09/2017 Patient Sequence Number: 1