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

Model Number 7163

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first date of the month of aware date as no information was provided.

Event Description

It was reported that balloon rupture occurred.A 2.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.No patient complications were reported.

Event Description

It was reported that balloon rupture occurred.A 2.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.No patient complications were reported.

Manufacturer Narrative

B3.Date of event: used the first date of the month of aware date as no information was provided.Returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.At 2.3cm from the strain relief there was a kink in the hypotube.At 41cm form the strain relief, the hypotube was bent.There was contrast and blood in the inflation lumen and balloon.The rapid port exchange (rpe) was torn, and at 4.6cm from the rpe, the shaft was kinked.There was blood in the guidewire lumen and the balloon.The balloon was loosely folded.There was a pinhole in the balloon located at the proximal end of the balloon at the waist cone transition.

• 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: 12926769
• MDR Text Key: 281748778
• Report Number: 2134265-2021-15223
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

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: 07/03/2023
• Device Model Number: 7163
• Device Catalogue Number: 7163
• Device Lot Number: 0026306769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2020
• 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