MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7163

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube is separated 64.5cm from the hub and appears to have been kinked prior to separation.Microscopic examination revealed no additional damages.There is contrast present in the inflation lumen and on the balloon folds.There is blood in the guide wire lumen and the balloon is still tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed on (b)(6) 2019.It was reported that balloon damage occurred.Vascular access was obtained via the right radial artery.The target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 1.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, during retreat of the device form the vessel, the balloon catheter got damaged.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed shaft detached/separated.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangi ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8545267
• MDR Text Key: 142935983
• Report Number: 2134265-2019-04263
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2020
• Device Model Number: 7163
• Device Catalogue Number: 7163
• Device Lot Number: 0022082156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2018
• 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