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

Model Number	7134
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties were encountered.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified mid left anterior descending artery.A 2.50mm 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.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.
Additional Manufacturer Narrative
Returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely tightly folded.Microscopic inspection revealed tip damage.There was a longitudinal tear 18mm long starting 3mm proximal from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that removal difficulties were encountered.The 95% stenosed target lesion was located in the moderately tortuous and mildly calcified mid left anterior descending artery.A 2.50mm 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.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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11483710
• Report Number: 2134265-2021-02367
• Device Sequence Number: 3412341
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0024745348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 65