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

Model Number	6532
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that the balloon raptured.The 70% stenosed target lesion was located in the non-tortuous and non-calcified distal right coronary artery.A 15mm x 4.00mm nc quantum apex catheters was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter address: (b)(6).Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.Microscopic examination revealed that the tip is damaged.There is a pinhole in the balloon 5mm from the tip.There are two scratch marks at the pinhole approximately 3mm and 8mm long.The balloon is loosely folded.There is no indication the device was inflated over rated burst pressure.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the balloon ruptured.The 70% stenosed target lesion was located in the non-tortuous and non-calcified distal right coronary artery.A 15mm x 4.00mm nc quantum apex catheters was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications nor injuries were reported.

• 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: 8200981
• Report Number: 2134265-2018-64669
• Device Sequence Number: 13488171
• Product Code: LOX
• UDI-Device Identifier: 08714729783411
• UDI-Public: 08714729783411
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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: 07/10/2021
• Device Model Number: 6532
• Device Catalogue Number: 6532
• Device Lot Number: 0022358889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 106