MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERJECT; BIOPSY NEEDLE KIT

Model Number M00518301

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an interject needle was opened on (b)(6) 2021.During preparation, the physician found hair contamination.It was reported that the device was not unpacked.There was no patient involvement in this case.

Manufacturer Narrative

H6: medical device problem code a1802 captures the reportable event of packaging foreign matter.H10: investigation results the returned unpackaged optiflo hemostasis catheter was analyzed, a visual evaluation was performed and a hair was observed inside the package.No other issues were noted.Based on all available information and the condition of the returned device, problems traced to the failure to maintain or establish techniques for controlling and verifying the product specifications (including materials used) identified by the manufacturer himself.The investigation concluded the most probable cause is quality control deficiency.There is an investigation in place to address this issue.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an interject needle was opened on (b)(6) 2021.During preparation, the physician found hair contamination.It was reported that the device was not unpacked.There was no patient involvement in this case.

• Brand Name: INTERJECT
• Type of Device: BIOPSY NEEDLE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12044305
• MDR Text Key: 257759558
• Report Number: 3005099803-2021-02781
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 08714729296508
• UDI-Public: 08714729296508
• Combination Product (y/n): N
• PMA/PMN Number: K171454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

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: 01/17/2024
• Device Model Number: M00518301
• Device Catalogue Number: 1830
• Device Lot Number: 0026647311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/22/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1