MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX RX PUSHER; CATHETER, BILIARY, DIAGNOSTIC

Model Number UNK-P-ADVANIX_PANCREATIC

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

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

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).

Event Description

It was reported to boston scientific corporation that on (b)(6) 2022, the inner box of an advanix pancreatic stent was found damaged.There was no procedure and patient involved in this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a020503 captures the reportable event of packaging seal compromised.Block h11: block h6 device code has been corrected from unsealed device packaging (a020503) to tear, rip or hole in device packaging (a020504) based on the photo provided of the complaint device that showed minimal packaging damaged and the device seal was not compromised.Boston scientific no longer considers this to be a reportable event.

Event Description

It was reported to boston scientific corporation that on december 21, 2022, the inner box of an advanix pancreatic stent was found damaged.There was no procedure and patient involved in this event.

• Brand Name: NAVIFLEX RX PUSHER
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16152963
• MDR Text Key: 308609396
• Report Number: 3005099803-2022-08084
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: UNK-P-ADVANIX_PANCREATIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1