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

Model Number 7133

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.Microscopic examination revealed a pinhole with scratch at the proximal markerband.Microscopic examination of the balloon presented no irregularities in the balloon material or the ro marker that could have contributed to the damage.The tip was damaged.The damage to the balloon and tip are consistent with interaction with the lesion.The reported balloon burst was confirmed.

Event Description

Reportable based on device analysis completed on 30-jan-2020.It was reported that tip damage occurred.The 85% stenosed, 18mmx2.5mm target lesion was located in the severely tortuous and moderately calcified distal end of left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was selected for use.However, during procedure, the tip of the balloon got kinked.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient's status was stable.However, returned device analysis revealed balloon pinhole.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9733105
• MDR Text Key: 180603704
• Report Number: 2134265-2020-01594
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113220
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0023272465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2019
• 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 Age: 69 YR
• Patient Weight: 68