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	09/23/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11483729
• Report Number: 2134265-2021-02432
• Device Sequence Number: 14305872
• Product Code: LOX
• UDI-Device Identifier: 08714729806295
• UDI-Public: 08714729806295
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121196
• 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): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 54