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

Model Number H7493912412250

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that product sterility was compromised.During unpacking of a 12mm x 2.50mm nc quantum apex¿ balloon catheter, difficulties were encountered while opening the package and the sterile pouch ripped down the middle of the sealed chevron tab, compromising the device's sterility.The device never entered the patient's body and the procedure was completed with a different balloon catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the returned product consisted of an nc quantum apex catheter in its original product pouch.The packaging was examined.The product pouch was received with the tyvek portion torn open.The tyvek portion is ripped.There was no damage to the device.Inspection of the remainder of the packaging and device, revealed no other damage or irregularities.No other issues were identified during the product analysis.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that product sterility was compromised.During unpacking of a 12mm x 2.50mm nc quantum apex¿ balloon catheter, difficulties were encountered while opening the package and the sterile pouch ripped down the middle of the sealed chevron tab, compromising the device's sterility.The device never entered the patient's body and the procedure was completed with a different balloon catheter.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: 6995483
• MDR Text Key: 91349952
• Report Number: 2134265-2017-10875
• 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: 10/16/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: H7493912412250
• Device Catalogue Number: 39124-1225
• Device Lot Number: 20139783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/01/2017
• Supplement Dates Manufacturer Received: 11/03/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2017
• 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