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

Model Number 7134

Device Problems Difficult to Remove (1528); Device-Device Incompatibility (2919)

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

Event Date 09/23/2020

Event Type  malfunction  

Event Description

It was reported that removal difficulties were encountered.The 85% stenosed target lesion was located in the middle segment of right coronary artery.A 1.50mm x 20mm emerge balloon catheter was advanced for post-dilatation of a non-bsc implanted stent.The emerge balloon catheter was fully deflated prior withdrawal.Resistance was felt during withdrawal at the lesion site.The non-bsc implanted stent migrated from the target lesion.Additional stenting was required as a result of the migrated non-bsc stent.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of the emerge balloon catheter.The hypotube, shaft, balloon and tip were microscopically and visually examined.The hypotube was separated at 64.9cm from the strain relief, and there were numerous kinks on the device.Blood was present in the guidewire lumen and the balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported device removal difficulties.As there was separation to the device and multiple kinks.

Event Description

It was reported that removal difficulties were encountered.The 85% stenosed target lesion was located in the middle segment of right coronary artery.A 1.50mm x 20mm emerge balloon catheter was advanced for post-dilatation of a non-bsc implanted stent.The emerge balloon catheter was fully deflated prior withdrawal.Resistance was felt during withdrawal at the lesion site.The non-bsc implanted stent migrated from the target lesion.Additional stenting was required as a result of the migrated non-bsc stent.There were no patient complications reported and the patient's status was stable.

• 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: 11483729
• MDR Text Key: 239747805
• Report Number: 2134265-2021-02432
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806295
• UDI-Public: 08714729806295
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K121196
• 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,Followup
• Report Date: 04/27/2021

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: 10/23/2020
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0021791573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• 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
• Patient Age: 73 YR
• Patient Weight: 54