MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC QUANTUM APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493912415220

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that balloon rupture and detachment occurred.A 15mm x 2.25mm nc quantum apex¿ balloon catheter was advanced for dilation.However, during inflation the balloon ruptured.Furthermore, when the device was removed, it was noted that the balloon portion was separated.No patient complications were reported and the patient's status was okay.

Manufacturer Narrative

Device returned to mfr., device evaluated by mfr.Last name corrected from (b)(6) to (b)(6).Initial reporter phone corrected from (b)(6) to (b)(6).Occupation corrected from health professional to physician.(b)(4).

Event Description

It was further reported that the target lesion was located in a mildly tortuous and mildly calcified vessel.On the fourth inflation at 20 atmospheres for 15 seconds, the balloon ruptured.The device was completely removed from the patient's body.

Event Description

It was further reported that the target lesion was located in a mildly tortuous and mildly calcified vessel.On the fourth inflation at 20 atmospheres for 15 seconds, the balloon ruptured.The device was completely removed from the patient's body.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an nc quantum apex balloon catheter.The balloon was loosely folded with blood in the lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.There are numerous hypotube and shaft kinks.Microscopic examination of the device presented that a portion of the outer shaft was plastically deformed proximal of the proximal balloon weld which also has a 8mm longitudinal tear.The balloon is intact and has no damage.There was no evidence of any material or manufacturing deficiencies contributing to the damage.There is no indication the device was inflated over the rated burst pressure.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: NC QUANTUM APEX¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7621952
• MDR Text Key: 111901470
• Report Number: 2134265-2018-05462
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: H7493912415220
• Device Catalogue Number: 39124-1522
• Device Lot Number: 21937404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1