MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC QUANTUM APEX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	6532
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occured.The procedure was indicated due to st segment myocardial infarction (stemi).A 15mm x 3.25mm nc quantum apex balloon catheter was advanced to post-dilate a stent n the proximal portion of the vessel.However, during deflation, it was noted that the balloon was unable to deflate using the indeflator.A new indeflator and stopcock were attached to the balloon catheter but still failed to deflate the balloon again.The physician was able to pull the balloon into the guide catheter and remove it from the patient's body.The procedure was completed with this device.There were no patient complications nor injuries reported and patient is doing well.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc quantum apex balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was soaked in a water bath for three days to loosen the blood and contrast in the device.Functional testing consisted of using a test inflation device to deflate the balloon.The balloon was able to deflate.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported difficulties deflating the balloon.
Event or Problem Description
It was reported that balloon deflation failure occured.The procedure was indicated due to st segment myocardial infarction (stemi).A 15mm x 3.25mm nc quantum apex balloon catheter was advanced to post-dilate a stent n the proximal portion of the vessel.However, during deflation, it was noted that the ballon was unable to deflate using the indeflator.A new indeflator and stopcock were attached to the balloon catheter but still failed to deflate the balloon again.The physician was able to pull the balloon into the guide catheter and remove it from the patient's body.The procedure was completed with this device.There were no patient complications nor injuries reported and patient is doing well.

• Brand Name: NC QUANTUM APEX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8752439
• Report Number: 2134265-2019-07043
• Device Sequence Number: 19342337
• Product Code: LOX
• UDI-Device Identifier: 08714729783381
• UDI-Public: 08714729783381
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: 04/09/2022
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0023621898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1