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

Model Number	7136
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in the middle left anterior descending artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilatation.However, the balloon twined with the guidewire.The entrapped devices were removed and the procedure was completed with a different device.No patient complications were reported and patient status was stable.
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in the middle left anterior descending artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilatation.However, the balloon twined with the guidewire.The entrapped devices were removed and the procedure was completed with a different device.No patient complications were reported and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: 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 contrast in balloon.The balloon was loosely folded.The device was functionally tested with a guidewire.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: EMERGE PUSH
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11216224
• Report Number: 2134265-2021-00628
• Device Sequence Number: 3795426
• Product Code: LOX
• UDI-Device Identifier: 08714729806042
• UDI-Public: 08714729806042
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130391
• 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): 03/30/2021

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: 05/01/2022
• Device Model Number: 7136
• Device Catalogue Number: 7136
• Device Lot Number: 0024371510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 59