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

Model Number 7132

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: used (b)(6) 2019 as the provided event date was (b)(6) 2019.

Event Description

It was reported via medwatch that a shaft break occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm emerge balloon catheter was selected for use.However, while advancing the device the balloon catheter snapped.No known patient complications were reported.

Event Description

It was reported via medwatch that a shaft break occurred.The target lesion was located in a coronary artery.A 2.50mm x 12mm emerge balloon catheter was selected for use.However, while advancing the device the balloon catheter snapped.No known patient complications were reported.It was further reported that the 80% stenosed target lesion was located in the severely tortuous and severely calcified ostial right coronary artery.The device broke after the monorail and was completely removed through a normal method.The procedure was completed with another 2.50mm x 12mm emerge balloon catheter and the patient did well.

Manufacturer Narrative

Date of event and describe event or problem updated.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8479056
• MDR Text Key: 140790735
• Report Number: 2134265-2019-03348
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• Combination Product (y/n): N
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2021
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0023230211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 04/08/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 72