MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMPLATZ SUPER STIFF; WIRE, GUIDE, CATHETER

Model Number 39575

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that foreign material on the device occurred.A 035/260/1 (bx/1) amplatz super stiff guidewire was selected for use.However, a foreign substance was observed before the device was opened.The procedure was completed with another of the same device.

Manufacturer Narrative

E1: initial reporter city: (b)(6).

Event Description

It was reported that foreign material on the device occurred.A 035/260/1 (bx/1) amplatz super stiff guidewire was selected for use.However, a foreign substance was observed before the device was opened.The procedure was completed with another of the same device.It was further reported that there was no foreign matter noticed on the device itself, but was mixed in the packaging.There was also no observed issue with the packaging.

Manufacturer Narrative

E1.Initial reporter city: (b)(6).Device evaluated by mfr: unit returned with its original unopened pouch batch 27861849.The returned pouch matches with upn/product family provided by the customer.One original pouch was returned for analysis.The pouch was closed and no open section was identified, however, a foreign matter was observed inside the package.There were no visual defects, contamination or damages observed on the pouch.The foreign matter was measured and the result was 0.80 mm2 which is within the maximum size allowed.

Event Description

It was reported that foreign material on the device occurred.A 035/260/1 (bx/1) amplatz super stiff guidewire was selected for use.However, a foreign substance was observed before the device was opened.The procedure was completed with another of the same device.It was further reported that there was no foreign matter noticed on the device itself, but was mixed in the packaging.There was also no observed issue with the packaging.

• Brand Name: AMPLATZ SUPER STIFF
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12771867
• MDR Text Key: 280822979
• Report Number: 2134265-2021-13977
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729295655
• UDI-Public: 08714729295655
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K843012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39575
• Device Catalogue Number: 39575
• Device Lot Number: 0027861849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• 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