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

Model Number H7493912412370

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a shaft expansion occurred.A 12mm x 3.75mm nc quantum apex¿ balloon catheter was selected for use to dilate the lesion.However, a "bubble on shaft" was noted.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the returned product consisted of a nc quantum apex balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube is kinked 12cm from the hub.Inspection of the device presented no damage or irregularities.The uv bond location is visible, but is within specification.Functional testing was carried out by attaching an inflation device filled with water to the hub of the complaint device, and inflating the device to rated burst pressure (rbp).The nc quantum apex device inflated and held pressure for 5 minutes without leaking.There was no evidence of any material or manufacturing deficiencies contributing to the damage.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that a shaft expansion occurred.A 12mm x 3.75mm nc quantum apex¿ balloon catheter was selected for use to dilate the lesion.However, a "bubble on shaft" was noted.No patient complications were reported.

• 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
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7206181
• MDR Text Key: 97968205
• Report Number: 2134265-2018-00231
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2020
• Device Model Number: H7493912412370
• Device Catalogue Number: 39124-1237
• Device Lot Number: 21275135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1