MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) THE MAGNET¿; WIRE, GUIDE, CATHETER

Model Number H74908966011

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that a "mysterious" string was caught inside the magnet.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device avail for eval, returned to mfr on, device returned to mfr, device evaluated by mfr, eval summary attached, method codes, result codes, conclusion codes: updated.Device evaluated by mfr: the device was returned with its original box and pouch.It has a magnetically attached spring in the magnets area of the device.The found spring is consistent with the used for the handle lock mechanism.The root cause as been determined to be manufacturing related.(b)(4).

Event Description

It was reported that a "mysterious" string was caught inside the magnet.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: THE MAGNET¿
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5049025
• MDR Text Key: 25399695
• Report Number: 2134265-2015-05846
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942333
• 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: Followup
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2017
• Device Model Number: H74908966011
• Device Catalogue Number: 08966-01
• Device Lot Number: 17915661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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