MAUDE Adverse Event Report: PEARLAND IMPRESS DIAGNOSTIC CATHETER

Catalog Number 510035SIM2

Device Problems Fracture (1260); Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return.A follow up will be submitted when the evaluation is complete.

Event Description

The physician alleges that during a vascular procedure the catheter tip detached within the patients aortic arch.A vascular snare device was used to successfully remove part of the catheter tip however, during removal, the catheter tip fragmented again and migrated to the patient's common femoral artery.The patient was taken to surgery were the catheter tip fragments were successfully removed.Patient recovered satisfactorily.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed and the root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.

Event Description

The account reported that the patient currently has an infection at the surgical site where the vascular surgery was performed.

• Brand Name: IMPRESS DIAGNOSTIC CATHETER
• Type of Device: DIAGNOSTIC CATHETER
• Manufacturer (Section D): PEARLAND; merit medical systems, inc.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): PEARLAND; merit medical systems, inc.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 94095 ; 8012531600
• MDR Report Key: 6835735
• MDR Text Key: 84281915
• Report Number: 3010665433-2017-00051
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 510035SIM2
• Device Lot Number: E677364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention