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

Model Number 7163

Device Problems Difficult to Advance (2920); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older. Device evaluated by mfr. : returned product consisted of the emerge balloon catheter with no hub. The shaft, hypotube, tip and balloon were microscopically and visually examined. There was contrast in the inflation lumen and blood in the guidewire lumen. The balloon was tightly folded. Inspection of the device did not present any kinks in the shaft at the balloon or tip. However, it was revealed that the device was received with no hub attached to the hypotube. Further inspection revealed that the hypotube was fractured. So, the length of the returned device was measured with a calibrated ruler and it was found that the returned length was 120. 5cm from the separation to the tip of the device. The catheter length from the distal end of the manifold strain relief to the distal tip is 144 +/- 5 cm. Indicating that approximately 23. 5cm of the hypotube was not returned along with the hub. Therefore, the hypotube separated 23. 5cm from the strain relief. The separated end of the hypotube was ovaled, indicating the hypotube was kinked prior to separation.

Event Description

Reportable based on device analysis completed on 17-dec-2020. It was reported that shaft kink and difficulty advancing were encountered. Vascular access was obtained via right radial artery. The 90% stenosed, 94x3-4. 00mm, eccentric, de novo target lesion was located in the mildly calcified proximal to distal right coronary artery (rca). After a 6f non-bsc guide catheter and a non-bsc guidewire were crossed the lesion, pre-dilation in the distal rca was performed with a 2. 50 x 15 emerge balloon catheter. Further dilation was performed with a 3. 00 x 15 emerge balloon catheter but failed to advance due to a kink on the shaft of the balloon. Another 3. 00 x 15 emerge balloon catheter was then used. The proximal rca was then pre-dilated with a 3. 5x15 emerge balloon catheter and a 3. 00x48 synergy drug-eluting stent (des) was deployed in the mid to distal rca and a 3. 50x48 synergy des in the proximal to mid rca. The proximal stented region of the rca was then post-dilated with a 4. 00mm x 8mm nc emerge balloon catheter. However, during inflation, the balloon burst. The device was removed from the patient's body and the procedure was completed with a 4. 00x12 nc emerge balloon catheter. No patient complications reported and the patient's status was stable. However, returned device analysis revealed shaft break.

• 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: 11109059
• MDR Text Key: 224859563
• Report Number: 2134265-2020-18690
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 7163
• Device Catalogue Number: 7163
• Device Lot Number: 0024442038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2019
• 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: 01/04/2021 Patient Sequence Number: 1

Treatment

GUIDE CATHETER (LAUNCHER SAL1.0SH 6F); GUIDEWIRE (ASAHI SION BLACK)